ClinicalTrials.gg
RecruitingNCT07798284Updated Oct 16, 2026

A Clinical Trial of TQF3250 Capsules in Overweight/Obese Trial Participants With Poor Weight Control Through Simple Lifestyle Intervention

A Phase 1 interventional study of TQF3250 capsules and TQF3250 placebo in Overweight/Obesity, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Recruiting at 10 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-16.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (part of Sino Biopharmaceutical Limited) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 16, 2026Now RecruitingSite recruiting status changedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase 1b clinical study. All trial participants are required to use TQF3250 capsules or placebo. The aim is to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of multiple administrations of TQF3250 capsules. A total of 80 trial participants are required.

02

Conditions studied

  • Overweight/Obesity

Browse trials for

03

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 80 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 320 studies on the registry; 76 are open to participants now.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Key inclusion criteria:

    1. During screening, trial participants must be aged 18 to 65 (inclusive), and can be male or female;
    2. During screening, obese individuals with a of 28 to less than 40 kg/m2, or overweight individuals with a BMI of 24 to less than 28 kg/m2 accompanied by at least one of the weight-related comorbidities.
    3. According to the self-reported information of the trial participants, they had undergone at least 3 months of simple lifestyle intervention before screening, and their weight change in the past 3 months was less than 5%.
    4. Women of childbearing age should agree to take effective measures during the study period and for 6 months after its completion (note: oral hormonal contraceptives should not be relied upon solely for contraception), and they must have a negative blood pregnancy test within 7 days prior to study enrollment; men should agree to take effective contraceptive measures during the study period and for 6 months after its completion.
    5. Volunteer to sign the form and are willing to strictly adhere to the requirements and restrictions outlined in the informed consent form and this protocol throughout the entire research period, including but not limited to: managing diet and exercise lifestyle, taking the study medication as scheduled, keeping a research diary, and completing relevant questionnaires.

Exclusion criteria

Exclusion Criteria:

  • Key exclusion criteria:

    1. Trial participants whom researchers suspect may be allergic to the study drug or its components, or who have an allergic constitution;
    2. Participants who have used glucagon-like peptide-1 receptor (GLP-1R) agonists, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR) agonists, or GLP-1R/glucagon receptor (GCGR) agonists within the previous 3 months prior to screening;
    3. Screen for medications that have been used or are currently being used within the previous 3 months and have an impact on body weight, including: hormone medications (administered intravenously, orally, or intra-articularly), metformin, sodium-glucose co-transporter 2 (SGLT-2) inhibitors, thiazolidinediones (TZD), tricyclic antidepressants, medications for psychiatric disorders or sedatives (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, valproic acid derivatives, lithium salts), etc;
    4. Screen for individuals who have consumed Chinese herbal medicines, health supplements, or meal replacements that affect body weight within the previous 3 months;
    5. Screen for individuals who have used or are currently using weight-loss drugs within the previous 3 months, such as: sibutramine hydrochloride, orlistat, phenylbutyrate, phenylpropanolamine, clobenzolide, phentermine, amfepramone, lorcaserin, phentermine/topiramate combination, naltrexone/bupropion combination, etc;
    6. Participants who have participated in other clinical trials (and have received trial drug treatment) within the previous 3 months;
    7. Patients with previously diagnosed diabetes (including type 1 or type 2 diabetes, etc.);
    8. Screen for patients with fasting venous blood glucose levels ≥7.0 mmol/L or levels ≥6.5%;
    9. Participants who have experienced unexplained hypoglycemic events (blood glucose \<3.9 mmol/L) within the previous 1 month before screening;
    10. Have previously undergone or plan to undergo weight loss surgery during the study period (excluding acupuncture and moxibustion for weight loss, liposuction, or abdominal liposuction performed more than 1 year before screening);
    11. Obesity caused by secondary diseases or medications, including: elevated cortisol hormone levels (e.g., Cushing's syndrome), obesity caused by pituitary and hypothalamic damage, and obesity caused by diagnosed monogenic or syndromic conditions (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome);
    12. Any endocrine system disease (such as hyperthyroidism, acromegaly, Cushing's syndrome, etc.) that the investigator deems unsuitable for participation in the study (if the investigator deems the condition stable, and the aforementioned diseases have been stably treated with medication for more than 3 months, and are not expected to have a significant impact on body weight, enrollment may be allowed);
    13. Previous history of depression; suicidal tendencies or suicide attempts, or previous history of severe mental illnesses, such as schizophrenia, bipolar disorder, etc;
    14. Resting blood pressure: Systolic Blood Pressure≥ 160 mmHg or \< 90 mmHg, and/or diastolic blood pressure≥ 100 mmHg (a retest is allowed after 10 minutes, and the retest value shall prevail), or new/changed antihypertensive medications or adjusted antihypertensive medication doses within 4 weeks before screening;
    15. Having any malignant tumor within the past 5 years (excluding basal cell carcinoma that has undergone curative treatment and is considered cured);
    16. Before screening, individuals with a history of major cardiovascular and cerebrovascular diseases within the past 6 months are defined as:

      1. History of myocardial infarction, unstable angina, coronary artery angioplasty or bypass surgery, valvular heart disease or valvular heart surgery, clinically significant arrhythmia, , or cerebrovascular accident; or
      2. Congestive heart failure with (NYHA) classification of III or IV;
    17. Screen for hemorrhagic or ischemic stroke or transient ischemic attack that occurred within the previous 6 months;
    18. Individuals with a history or family history of medullary thyroid cancer, multiple endocrine neoplasia (MEN) 2A or 2B, or genetic diseases that are prone to induce medullary thyroid cancer during screening;
    19. During screening, patients with a history of acute or chronic pancreatitis, pancreatic injury, or clinically significant gallbladder or bile duct diseases (excluding gallbladder polyps that do not require clinical intervention) are excluded;
    20. Previously had clinically significant gastric emptying abnormalities (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as active ulcer within 6 months before screening), long-term use of drugs with direct effects on gastrointestinal motility, or underwent gastrointestinal surgery (excluding endoscopic resection of gastrointestinal polyps, etc.);
    21. Individuals with physical deformities or mutilations, making it impossible to accurately determine their height, weight, and other indicators;
    22. Participants who have undergone major or medium-sized surgery, severe trauma, or severe infection within one month prior to screening, and are deemed unsuitable for participation in this study by the investigator;
    23. History of organ transplantation, or history of other acquired or congenital immune system diseases;
    24. During the trial, there were anticipated surgeries, except for outpatient surgeries that the researchers determined had no impact on the safety of trial participants and the trial results;
    25. During screening, if the virological test indicates any of the following conditions:

    <!-- -->

    1. antibody is positive, and the detection value of HCV viral load (HCV RNA) exceeds the ;
    2. is positive, and the HBV DNA detection value exceeds the upper limit of normal range;
    3. -positive;
    4. Active syphilis: Treponema pallidum antibody is positive during the screening period, and the non-treponemal serological test is also positive.

    26. Screen for individuals who have received or plan to receive or attenuated live vaccines within 30 days prior to the study. Inactivated vaccines (including inactivated influenza vaccines) are not subject to this restriction, but the vaccination status should be accurately recorded.

    27. Screen for individuals who have regularly consumed alcohol within the previous 3 months, specifically those who have consumed more than 14 units of alcohol per week (1 unit equals 360 mL of beer, 45 mL of spirits with 40% alcohol content, or 150 mL of wine); or those who have exhibited clinically significant abnormalities in blood alcohol testing during the screening period; or those who are unable to adhere to the protocol's prohibition on alcohol consumption; 28. Screen out smokers who have smoked more than 10 cigarettes per day for the previous 3 months or who cannot quit smoking during the pharmacokinetic intensive blood sampling period; 29. Individuals with a history of drug abuse, drug dependence, or use of drugs within the previous year, or those who tested positive for drugs in urine screening prior to drug administration, shall be screened out; 30. During screening, serum calcitonin should be ≥20ng/L; 31. During screening, the (ALT) level must be ≥2.0× ULN and/or the aspartate aminotransferase (AST) level must be ≥2.0× ULN and/or the total level must be ≥1.5× ULN and/or the alkaline phosphatase (ALP) level must be ≥2.0× ULN; 32. During screening, the (eGFR) should be less than 60 mL/min/1.73 m2, calculated according to the CKD-EPI 2021 formula; 33. Screen for participants with fasting triglyceride levels ≥5.65 mmol/L (500 mg/dl). If the participants are undergoing lipid-lowering treatment, the type and dosage of medication should be stable for at least 30 days before screening, and in principle, they should remain unchanged during the study period; 34. During screening, the blood amylase or lipase level should be greater than 1.5× ULN; 35. During screening, the 12-lead shows a heart rate of \<50 beats per minute or >100 beats per minute (a retest is allowed after 10 minutes, and the retest value shall prevail); 36. During screening, the following clinically significant abnormalities in 12-lead electrocardiograms (ECGs) are considered: second-degree or third-degree atrioventricular block, long syndrome or QTcF >450ms, PR interval \<120ms or PR interval >220ms, QRS >120ms, left or right bundle branch block, pre-excitation syndrome, or other severe arrhythmias requiring treatment; 37. History of other risk factors for Torsade de Pointes (TdP) ventricular tachycardia, such as hypokalemia at screening, family history of Long QT Syndrome, or concurrent medication use that prolongs the QT/QTc interval at screening; 38. Individuals who have donated blood and/or lost blood volume ≥400mL within the previous 3 months, or have undergone bone marrow donation, or suffer from anemia-related diseases such as hemoglobinopathy, hemolytic anemia, sickle cell anemia, or have a level \<110g/L (male) or \<100g/L (female) before screening; 39. During screening, if any of the following conditions exist:

    a. Use of strong or moderate inhibitors or inducers within 28 days before screening, including but not limited to rifampin, rifapentine, carbamazepine, phenytoin, phenobarbital, St. John's wort, itraconazole, ketoconazole, voriconazole, ritonavir, cobistat, clarithromycin, etc; b. Those who are currently using simvastatin during screening and cannot discontinue it and switch to an alternative treatment regimen approved by the investigator; for those who have previously used simvastatin, they should discontinue it before screening and switch to an alternative treatment regimen approved by the investigator, and the alternative treatment regimen must be stable for at least 30 days before enrollment.

    40. Researchers believe that trial participants who possess any other factors that may affect the efficacy or safety evaluation of this study are not suitable to participate in this study.

Terms in these criteria, in plain language(20)

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.

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.

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.

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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.

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.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

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.

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.

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.

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.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

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.

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.

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.

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.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

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).

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    TQF3250 capsules

    This study established six treatment dose groups. Each group adopted a dose titration scheme, with trial participants titrating from a low dose to the target dose. Trial participants take TQF3250 capsules orally once daily for a total treatment period of 12 weeks.

    Drug: TQF3250 capsules

  • Placebo comparator
    TQF3250 Placebo

    The trial participants take TQF3250 placebo orally once daily, with a total treatment duration of 12 weeks.

    Drug: TQF3250 placebo

Interventions

  • An oral glucagon-like peptide-1 receptor agonist

  • DrugTQF3250 placebo

    Placebo contains no active substance.

06

What researchers measure

Primary outcomes

  1. Adverse Event

    Incidence and Severity of All Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Baseline up to 14 weeks

  2. Abnormal clinical examination findings

    Incidence of abnormal clinical laboratory examination, vital signs, physical examination, 12-lead electrocardiogram,etc.

    Time frame: Baseline up to 14 weeks

Secondary outcomes

  1. Area Under the Curve from 0 to 24 hours(AUC0-24h)

    AUC0-24h following the first administration at target dose, and AUC0-24h after multiple administrations

    Time frame: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.

  2. Area Under the Curve from time zero to infinity(AUC0-∞)

    AUC0-∞ following the first administration at target dose, and AUC0-∞ after multiple administrations

    Time frame: pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6hours post-dose Days 36,50,64,78; pre-1st dose & 1,2,4,6,8,12,24hours post target dose; pre-dose & 1,2,4,6,8,12,24hours post Days 35,42; pre-dose & 1,2,4,6,8,12,24,48,96hours post Day 84.

  3. Area Under the Curve from time zero to the last quantifiable time point(AUC0-t)

    AUC0-t after multiple administrations

    Time frame: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.

  4. Maximum Plasma Concentration(Cmax)

    Cmax following the first administration at target dose

    Time frame: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.

  5. Minimum Steady-State Concentration(Css-min)

    Css-min after multiple administrations

    Time frame: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.

  6. Maximum Steady-State Concentration(Css-max)

    Css-max after multiple administrations

    Time frame: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.

  7. Average Steady-State Concentration(Css-avg)

    Css-avg after multiple administrations

    Time frame: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.

  8. Elimination Half-Life(t1/2)

    t1/2 following the first administration at target dose and t1/2 after multiple administrations

    Time frame: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.

  9. Time to Maximum Concentration(Tmax)

    Tmax after multiple administrations

    Time frame: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.

  10. Apparent Oral Clearance (CL/F)

    CL/F following the first administration at target dose and CL/F after multiple administrations

    Time frame: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.

  11. Apparent Volume of Distribution during Elimination Phase(Vz/F)

    Vz/F following the first administration at target dose

    Time frame: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.

  12. Apparent Volume of Distribution at Steady State(Vss/F)

    Vss/F after multiple administrations

    Time frame: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.

  13. Terminal elimination rate constant(λz)

    λz following the first administration at target dose and λz after multiple administrations

    Time frame: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.

  14. Accumulation Ratio (Rac)

    Rac after multiple administrations

    Time frame: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.

  15. Dose Fluctuation(DF)

    DF after multiple administrations

    Time frame: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.

  16. Body Weight

    Percentage change in body weight compared to baseline, as well as the proportion of trial participants whose body weight decreased by ≥5%, ≥10%, and ≥15% compared to baseline

    Time frame: Baseline up to 12 weeks

  17. Body Mass Index (BMI)

    Change in BMI compared to baseline

    Time frame: Baseline up to 12 weeks

  18. Waist Circumference

    Change from baseline in waist circumference

    Time frame: Baseline up to 12 weeks

  19. Hip circumference

    Change from baseline in hip circumference

    Time frame: Baseline up to 12 weeks

  20. waist-to-hip ratio

    Change from baseline in waist-to-hip ratio

    Time frame: Baseline up to 12 weeks

  21. Glycated hemoglobin (HbA1c)

    Change from baseline in HbA1c

    Time frame: Baseline up to 12 weeks

  22. Fasting Plasma Glucose (FPG)

    Change from baseline in FPG

    Time frame: Baseline up to 12 weeks

  23. C-peptide

    Change in C-peptide compared to baseline

    Time frame: Baseline up to 12 weeks

  24. Insulin

    Change in Insulin compared to baseline

    Time frame: Baseline up to 12 weeks

  25. blood pressure

    Changes in systolic and diastolic blood pressure compared to baseline

    Time frame: Baseline up to 12 weeks

  26. blood lipids

    Changes in blood lipids compared to baseline

    Time frame: Baseline up to 12 weeks

07

Study locations

6 of 10 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 16, 2026
Sites
10 sites changed recruiting status (6 now recruiting, 4 now not yet recruiting)
Show 10 sites
  • Peking University People's Hospital · Beijing, Chinano status→Recruiting
  • Guangzhou First People's Hospital · Guangzhou, Chinano status→Recruiting
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University · Guangzhou, Chinano status→Not yet recruiting
  • Zhengzhou People's Hospital · Zhengzhou, Chinano status→Not yet recruiting
  • Zhongnan Hospital of Wuhan University · Wuhan, Chinano status→Recruiting
  • Xianning Central Hospital · Xianning, Chinano status→Recruiting
  • Central Hospital Affiliated to Shandong First Medical University · Jinan, Chinano status→Not yet recruiting
  • Shanghai Tenth People's Hospital · Shanghai, Chinano status→Recruiting
  • The Affiliated Hospital of Southwest Medical University · Luzhou, Chinano status→Not yet recruiting
  • The First People's Hospital of Xiaoshan Hangzhou · Hangzhou, Chinano status→Recruiting
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    Not yet recruiting→Recruiting
    10 sites changed recruiting status (6 now recruiting, 4 now not yet recruiting)
    Show 10 sites
    • Peking University People's Hospital · Beijing, Chinano status→Recruiting
    • Guangzhou First People's Hospital · Guangzhou, Chinano status→Recruiting
    • Sun Yat-sen Memorial Hospital, Sun Yat-sen University · Guangzhou, Chinano status→Not yet recruiting
    • Zhengzhou People's Hospital · Zhengzhou, Chinano status→Not yet recruiting
    • Zhongnan Hospital of Wuhan University · Wuhan, Chinano status→Recruiting
    • Xianning Central Hospital · Xianning, Chinano status→Recruiting
    • Central Hospital Affiliated to Shandong First Medical University · Jinan, Chinano status→Not yet recruiting
    • Shanghai Tenth People's Hospital · Shanghai, Chinano status→Recruiting
    • The Affiliated Hospital of Southwest Medical University · Luzhou, Chinano status→Not yet recruiting
    • The First People's Hospital of Xiaoshan Hangzhou · Hangzhou, Chinano status→Recruiting
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07798284
Responsible party
Sponsor
First posted
Sep 1, 2026
Start date
Sep 29, 2026
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Oct 16, 2026

Study contacts

Linong Ji, Doctor
Contact
jiln@bjmu.edu.cn
13910978815

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: TQF3250

Start the discussion