A Phase 1 interventional study of UBT251 and Metformin hydrochloride in Drug Drug Interaction (DDI) and Pharmacokinetics and Pharmacodynamics, sponsored by The United Bio-Technology (Hengqin) Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by The United Bio-Technology (Hengqin) Co., Ltd. (part of The United Laboratories International Holdings Limited) · Phase 1, Interventional, and Other
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Among 599 studies in Obesity with a site in China — 220 open to participants now, 281 under way, 67 of them phase 3. Obesity · China.
Among the 599 studies in Obesity with a site in China, this one is the 397th largest by planned enrollment of the 501 interventional ones that give a count, is one of 133 that started in 2026, is one of 92 in phase 1, reaches primary completion later than 103 of the 279 other live ones, and was the 536th registered.
11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.
Browse Obesity studies →220 of the 599 studies in Obesity with a site in China are open now. Recruiting first, the newest first:
The First Hospital of Jilin University · Sites in China
Ages 18–65
Pfizer · Sites in China
Ages 18+
Eli Lilly and Company · Sites in China, United States, Brazil and 7 more countries
Ages 18+
The United Bio-Technology (Hengqin) Co., Ltd. · Sites in China
Ages 18–55
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Sites in China
Ages 18–65
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 1,339 Obesity studies recruiting now, 377 (28%) set no upper age limit and 859 (64%) stop at 75 or younger; 167 take children under 18; 490 take healthy volunteers.
This study: 18 Years to 45 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
599 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 102 · Phase 2 70 · Phase 3 108 · Phase 4 28
First in 1997; this study’s year is marked. 133 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 48 is below the median of 67 across 9,016 interventional studies indexed under Obesity.
Median enrollment 120 across the 501 interventional studies, 310 across the 98 observational. Of the 241 that completed or were terminated, 13 (5%) have results posted.
This tab as a report to print or save as PDF → With an account.
240 of 599 have an industry lead sponsor. The 10 most frequent:
This study is registered under The United Bio-Technology (Hengqin) Co., Ltd., one of the names counted as The United Laboratories International Holdings Limited. Under that name alone:
The United Bio-Technology (Hengqin) Co., Ltd. is the lead sponsor of 13 studies on the registry; 10 are open to participants now.
The United Laboratories International Holdings Limited has 8 studies filed under Obesity — fewer than ten, so there is no comparison to draw.
104 of the studies in Obesity with a site in China that are under way reach primary completion within a year, 20 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06974851Phase 3Fujian Shengdi Pharmaceutical Co., Ltd.A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity | 2026-12 |
| NCT06994650Phase 3Fujian Shengdi Pharmaceutical Co., Ltd.A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy | 2026-12 |
| NCT06672549Phase 3Eli Lilly and CompanyA Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040) | 2027-02 |
| NCT07481747Phase 3Hudson BiotechEfficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1) | 2027-02-14 |
| NCT07285902Phase 3Fujian Shengdi Pharmaceutical Co., Ltd.A Study Comparing the Efficacy and Safety of HRS9531 Injection With Semaglutide Injection in Subjects With Obesity | 2027-03 |
Add all 104 to your calendar (.ics) → With an account.
Among the 599 studies in Obesity with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a Phase I, open-label, two-cohort study designed to evaluate the drug-drug interaction potential of multiple-dose UBT251 Injection in adult participants with overweight or obesity.
The primary objective of Cohort 1 is to evaluate the effect of UBT251 Injection on the pharmacokinetic (PK) profiles of metformin and warfarin. The secondary objectives of Cohort 1 are to assess the influence of UBT251 Injection on the pharmacodynamic (PD) characteristics of warfarin, to evaluate the safety of UBT251 Injection administered alone, as well as metformin and warfarin administered alone or in combination with UBT251 Injection, and to characterize the PK, PD, and immunogenicity profiles following repeated UBT251 Injection dosing.
The primary objective of Cohort 2 is to evaluate the effect of UBT251 Injection on the PK profiles of atorvastatin and digoxin. The secondary objectives of Cohort 2 are to evaluate the safety of UBT251 Injection alone, atorvastatin and digoxin alone, and their combination with UBT251 Injection, as well as to assess the PK, PD, and immunogenicity characteristics after multiple administrations of UBT251 Injection.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
History or evidence of any of the following diseases:
Any clinically significant laboratory abnormality meeting any of the following criteria at screening:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study contains two cohorts. Cohort 1: Participants will first receive multiple-dose metformin, then a single-dose warfarin after a 7-day washout period, with PK/PD sampling for both treatments. Following a 20-week weekly dose-escalation phase of UBT251, metformin will be administered 24 hours after the 5th consecutive fixed-dose UBT251 injection, and warfarin will be given 24 hours after the 6th injection. Dosing and PK/PD sampling procedures will match those of the single-drug phase. Cohort 2: Participants will receive single-dose atorvastatin and digoxin separated by a 7-day washout period, with PK sampling for each drug. After the 20-week UBT251 weekly dose-escalation phase, atorvastatin will be given 24 hours after the 5th consecutive fixed-dose UBT251 injection, and digoxin will be administered 24 hours after the 6th injection. PK sampling procedures will be consistent with those of the single-drug treatment phase.
Drug: UBT251 · Drug: Metformin hydrochloride · Drug: Warfarin Sodium · Drug: Atorvastatin calcium · Drug: Digoxin
Subcutaneous injection administered once weekly with dose escalation
Oral administration. Metformin hydrochloride will be given as twice-daily doses for 7 consecutive administrations.
Oral administration. Warfarin sodium will be given as 2 single doses.
Oral administration. Atorvastatin calcium will be given as 2 single doses.
Oral administration. Digoxin will be given as 2 single doses.
Area under plasma concentration-time curve of metformin (AUC0-τ) and S-warfarin, R-warfarin (AUC0-t, AUC0-∞)
Compare AUC0-τ of metformin after multiple-dose administration alone, and AUC0-t and AUC0-∞ of S-warfarin and R-warfarin after single-dose administration alone, with the corresponding parameters when these drugs are administered following dose-escalated and continued 6.0 mg UBT251 in Cohort 1.
Time frame: From time 0 to 30 hours (metformin, post last dose) and 168 hours (S-warfarin, R-warfarin) after respective doses
Area under plasma concentration-time curve (AUC0-t and AUC0-∞) of atorvastatin and digoxin
Compare AUC0-t and AUC0-∞ of single-dose atorvastatin and single-dose digoxin administered alone, with corresponding parameters when administered following dose-escalated and continued 6.0 mg UBT251 in Cohort 2.
Time frame: From time 0 to 72 hours (atorvastatin) and 120 hours (digoxin) after respective single doses
Peak Plasma Concentration (Cmax) of metformin in Cohort 1
Peak plasma concentration (Cmax) of metformin at steady-state in Cohort 1
Time frame: Up to 30 hours following last dose at steady-state
Time to Peak Plasma Concentration (Tmax) of metformin in Cohort 1
Time to reach peak plasma concentration (Tmax) of metformin at steady-state in Cohort 1
Time frame: Up to 30 hours following last dose at steady-state
Area under the plasma concentration-time curve from 0 to last measurable time point (AUC0-t) of metformin in Cohort 1
Area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUC0-t) of metformin at steady-state in Cohort 1
Time frame: Pre-dose and up to 30 hours following last dose at steady-state
Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) of metformin in Cohort 1
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞) of metformin at steady-state in Cohort 1
Time frame: Pre-dose and up to 30 hours following last dose at steady-state
Apparent volume of distribution (Vz/F) of metformin in Cohort 1
Apparent volume of distribution (Vz/F) of metformin at steady-state in Cohort 1
Time frame: Pre-dose and up to 30 hours following last dose at steady-state
Apparent total clearance (CL/F) of metformin in Cohort 1
Apparent total clearance (CL/F) of metformin at steady-state in Cohort 1
Time frame: Up to 30 hours following last dose at steady-state
Terminal elimination rate constant (λz) of metformin in Cohort 1
Terminal elimination rate constant (λz) of metformin at steady-state in Cohort 1
Time frame: Pre-dose and up to 30 hours following last dose at steady-state
Terminal half-life (t1/2z) of metformin in Cohort 1
Terminal elimination half-life (t1/2z) of metformin at steady-state in Cohort 1
Time frame: Pre-dose and up to 30 hours following last dose at steady-state
Peak Plasma Concentration (Cmax) of S-warfarin in Cohort 1
Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates maximum plasma concentration (Cmax).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Time to Maximum Plasma Concentration (Tmax) of S-warfarin in Cohort 1
Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates time to maximum plasma concentration (Tmax).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Terminal Rate Constant (λz) of S-warfarin in Cohort 1
Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates terminal rate constant (λz).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Terminal Half-Life (t1/2z) of S-warfarin in Cohort 1
Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates terminal half-life (t1/2z).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Apparent Clearance (CL/F) of S-warfarin in Cohort 1
Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates apparent clearance (CL/F).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Apparent Volume of Distribution (Vz/F) of S-warfarin in Cohort 1
Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates apparent volume of distribution (Vz/F).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Maximum Plasma Concentration (Cmax) of R-warfarin in Cohort 1
Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates maximum plasma concentration (Cmax).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Time to Maximum Plasma Concentration (Tmax) of R-warfarin in Cohort 1
Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates time to maximum plasma concentration (Tmax).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Terminal Rate Constant (λz) of R-warfarin in Cohort 1
Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates terminal rate constant (λz).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Terminal Half-Life (t1/2z) of R-warfarin in Cohort 1
Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates terminal half-life (t1/2z).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Apparent Clearance (CL/F) of R-warfarin in Cohort 1
Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates apparent clearance (CL/F).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Apparent Volume of Distribution (Vz/F) of R-warfarin in Cohort 1
Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates apparent volume of distribution (Vz/F).
Time frame: Pre-dose and up to 168 hours following last dose at steady-state
Maximum Plasma Concentration (Cmax) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state maximum plasma concentration (Cmax).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Time to Maximum Plasma Concentration (Tmax) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state time to maximum plasma concentration (Tmax).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Time-point (AUC0-t) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state area under the concentration-time curve from zero to last measurable time-point (AUC0-t).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUC0-τ) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state area under the concentration-time curve over dosing interval (AUC0-τ).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Terminal Rate Constant (λz) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state terminal rate constant (λz).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Terminal Half-Life (t1/2z) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state terminal half-life (t1/2z).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Apparent Clearance (CL/F) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state apparent clearance (CL/F).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Apparent Volume of Distribution (Vz/F) of UBT251 in Cohort 1
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state apparent volume of distribution (Vz/F).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Maximum Plasma Concentration (Cmax) of Atorvastatin in Cohort 2
Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates maximum plasma concentration (Cmax).
Time frame: Pre-dose and up to 72 hours following single dose
Time to Maximum Plasma Concentration (Tmax) of Atorvastatin in Cohort 2
Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates time to maximum plasma concentration (Tmax).
Time frame: Pre-dose and up to 72 hours following single dose
Terminal Rate Constant (λz) of Atorvastatin in Cohort 2
Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal rate constant (λz).
Time frame: Pre-dose and up to 72 hours following single dose
Terminal Half-Life (t1/2z) of Atorvastatin in Cohort 2
Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal half-life (t1/2z).
Time frame: Pre-dose and up to 72 hours following single dose
Apparent Clearance (CL/F) of Atorvastatin in Cohort 2
Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates apparent clearance (CL/F).
Time frame: Pre-dose and up to 72 hours following single dose
Apparent Volume of Distribution (Vz/F) of Atorvastatin in Cohort 2
Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates apparent volume of distribution (Vz/F).
Time frame: Pre-dose and up to 72 hours following single dose
Maximum Plasma Concentration (Cmax) of 2-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates maximum plasma concentration (Cmax).
Time frame: Pre-dose and up to 72 hours following single dose
Time to Maximum Plasma Concentration (Tmax) of 2-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates time to maximum plasma concentration (Tmax).
Time frame: Pre-dose and up to 72 hours following single dose
Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Time-point (AUC0-t) of 2-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates area under the concentration-time curve from zero to last measurable time-point (AUC0-t).
Time frame: Pre-dose and up to 72 hours following single dose
Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC0-∞) of 2-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates area under the concentration-time curve from zero to infinity (AUC0-∞).
Time frame: Pre-dose and up to 72 hours following single dose
Terminal Rate Constant (λz) of 2-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal rate constant (λz).
Time frame: Pre-dose and up to 72 hours following single dose
Terminal Half-Life (t1/2z) of 2-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal half-life (t1/2z).
Time frame: Pre-dose and up to 72 hours following single dose
Maximum Plasma Concentration (Cmax) of 4-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates maximum plasma concentration (Cmax).
Time frame: Pre-dose and up to 72 hours following single dose
Time to Maximum Plasma Concentration (Tmax) of 4-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates time to maximum plasma concentration (Tmax).
Time frame: Pre-dose and up to 72 hours following single dose
Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Time-point (AUC0-t) of 4-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates area under the concentration-time curve from zero to last measurable time-point (AUC0-t).
Time frame: Pre-dose and up to 72 hours following single dose
Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC0-∞) of 4-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates area under the concentration-time curve from zero to infinity (AUC0-∞).
Time frame: Pre-dose and up to 72 hours following single dose
Terminal Rate Constant (λz) of 4-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal rate constant (λz).
Time frame: Pre-dose and up to 72 hours following single dose
Terminal Half-Life (t1/2z) of 4-hydroxy-atorvastatin in Cohort 2
Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal half-life (t1/2z).
Time frame: Pre-dose and up to 72 hours following single dose
Time to Maximum Plasma Concentration (Tmax) of Digoxin in Cohort 2
Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates time to maximum plasma concentration (Tmax).
Time frame: Pre-dose and up to 120 hours following single dose
Terminal Rate Constant (λz) of Digoxin in Cohort 2
Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates terminal rate constant (λz).
Time frame: Pre-dose and up to 120 hours following single dose
Terminal Half-Life (t1/2z) of Digoxin in Cohort 2
Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates terminal half-life (t1/2z).
Time frame: Pre-dose and up to 120 hours following single dose
Apparent Clearance (CL/F) of Digoxin in Cohort 2
Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates apparent clearance (CL/F).
Time frame: Pre-dose and up to 120 hours following single dose
Apparent Volume of Distribution (Vz/F) of Digoxin in Cohort 2
Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates apparent volume of distribution (Vz/F).
Time frame: Pre-dose and up to 120 hours following single dose
Maximum Plasma Concentration (Cmax) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state maximum plasma concentration (Cmax).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Time to Maximum Plasma Concentration (Tmax) of UBT251 in Cohort 2
Time to Maximum Plasma Concentration (Tmax) of UBT251 in Cohort 2
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Time-point (AUC0-t) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state area under the concentration-time curve from zero to last measurable time-point (AUC0-t).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUC0-τ) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state area under the concentration-time curve over dosing interval (AUC0-τ).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Terminal Rate Constant (λz) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state terminal rate constant (λz).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Terminal Half-Life (t1/2z) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state terminal half-life (t1/2z).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Apparent Clearance (CL/F) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state apparent clearance (CL/F).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Apparent Volume of Distribution (Vz/F) of UBT251 in Cohort 2
Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state apparent volume of distribution (Vz/F).
Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing
Area Under the INR-Time Curve (AUCINR) of Warfarin Under UBT251 Steady-State in Cohort 2
Serial INR measurements are collected to characterize the pharmacodynamic effect of warfarin, when administered under UBT251 steady-state conditions. This endpoint evaluates area under the INR-time curve (AUCINR).
Time frame: Baseline to 168 hours
Maximum Observed INR (INRmax) of Warfarin Under UBT251 Steady-State in Cohort 2
Serial INR measurements are collected to characterize the pharmacodynamic effect of warfarin administered under UBT251 steady-state conditions. This endpoint evaluates maximum observed INR (INRmax).
Time frame: Baseline to 168 hours
Change in Body Weight From Pre-treatment Baseline Following UBT251 Dosing in Cohort 2
Body weight is measured at baseline and scheduled visits. This endpoint evaluates body weight change relative to pre-UBT251 baseline.
Time frame: throughout UBT251 titration period
Incidence, Maximum Severity Grade, and Duration of Adverse Events and Serious Adverse Events During UBT251 Treatment
All adverse events and serious adverse events are actively monitored and recorded throughout the study. This outcome assesses the incidence defined as percentage of affected subjects, maximum severity grade classified according to CTCAE criteria, and duration in days of each adverse event.
Time frame: Baseline up to Study Day 190
Changes From Baseline in Vital Signs During UBT251 Treatment
Vital signs including systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature are measured using standard clinical equipment at scheduled visits. This outcome evaluates absolute and relative changes from baseline throughout the study period.
Time frame: Baseline up to Study Day 190
Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters During UBT251 Treatment
12-lead ECGs are collected at scheduled visits and can be additionally performed at any time for safety monitoring. Participants rest in a supine position for at least 5 minutes before testing. Assessed parameters include RR interval, PR interval, heart rate, QRS interval, QT interval, QTc interval, and QTcF calculated by Fredericia's formula. This outcome evaluates parameter changes from baseline and clinically significant abnormal ECG findings.
Time frame: Baseline up to Study Day 190
Clinically Significant Abnormal Findings on Complete Physical Examination During UBT251 Treatment
Complete physical examinations are performed at scheduled study visits, covering general condition, skin and mucous membranes, lymph nodes, head and neck, chest, abdomen, spine, and extremities. This outcome summarizes all clinically significant abnormal physical examination findings compared with baseline throughout the study period.
Time frame: Baseline up to Study Day 190
Changes From Baseline in Safety Laboratory Parameters During UBT251 Treatment
Safety laboratory tests include hematology, urinalysis, serum biochemistry, electrolytes, blood glucose, blood lipids, cardiac enzymes, lipase, amylase, coagulation function, glycated hemoglobin, procalcitonin, thyroid function tests, and infectious disease screening. This outcome evaluates changes from baseline and clinically significant laboratory abnormalities.
Time frame: Baseline up to Study Day 190
Incidence of Positive Anti-UBT251 Binding Antibodies in Subjects Receiving UBT251
Validated immunoassay is used as the measurement tool to detect anti-UBT251 binding antibodies. This outcome assesses incidence (percentage of subjects with positive binding antibodies) at scheduled sampling time-points including Study Day 15, 43, 127, 162 and 190.
Time frame: Baseline up to Study Day 190
Antibody Titer Level of Anti-UBT251 Binding Antibodies in Antibody-Positive Subjects
Validated immunoassay is used as the measurement tool to determine antibody titer. This outcome reports titer levels for specimens confirmed positive for anti-UBT251 binding antibodies at scheduled sampling time-points including Study Day 15, 43, 127, 162 and 190.
Time frame: Baseline up to Study Day 190
Incidence of Positive Anti-UBT251 Neutralizing Antibodies (If Applicable) in Subjects Receiving UBT251
Validated cell-based neutralizing antibody assay is used as the measurement tool. This outcome assesses incidence (percentage of subjects with positive neutralizing antibodies), if applicable, at scheduled sampling time-points including Study Day 15, 43, 127, 162 and 190.
Time frame: Baseline up to Study Day 190
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Started May 2026 (actual). Primary completion is estimated for Dec 2026, 7 months after the start.
Of 334 industry-sponsored phase 1 interventional studies under Obesity, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 15. This study's planned 7 months is below that.
Counting every sponsor, half of 439 studies reached it within 11 months; a quarter within 6 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: UBT251
The United Bio-Technology (Hengqin) Co., Ltd. →