ClinicalTrials.gg
Not yet recruitingNCT07935291Updated Nov 13, 2026

Study of IPG1094 Tablets in Chinese Healthy Adults and Obese Adults

A Phase 1 interventional study of IPG1094 Tablet and matching Placebo in Healthy Volunteers; Obesity, sponsored by Nanjing Immunophage Biotech Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Nanjing Immunophage Biotech Co., Ltd · Phase 1, Interventional, and Treatment

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

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.

Planned enrollment
328th of 501
72 · median 120
Started
2026
with 132 others
Phase 1
92 of 599
28 open now
Primary completion
2027-06
later than 168 of 279 live
Registered
594th of 599
by date

Among the 599 studies in Obesity with a site in China, this one is the 328th 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 168 of the 279 other live ones, and was the 594th registered.

Obesity

11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.

Browse Obesity studies →

Open to participants now

220 of the 599 studies in Obesity with a site in China are open now. Recruiting first, the newest first:

215 more — sign in →

All 220 open studies →

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 →

Who these studies take

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 50 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

Study summary

This is a Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary weight-loss effect of IPG1094 tablets. The study includes three parts: Part A is single ascending dose in healthy volunteers; Part B is multiple ascending dose in healthy volunteers; Part C is multiple-dose exploration in obese adult participants. Subjects will be randomly assigned to receive IPG1094 or matching placebo. Safety, blood drug concentration and weight-related indicators will be followed up.

03

Conditions studied

  • Healthy Volunteers; Obesity

Browse trials for

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  1. Male and female Chinese participants aged 18-50 years inclusive.
  2. Part A/B (healthy adults): Physical examination, vital signs, 12-lead , chest X-ray, laboratory tests are normal or abnormalities considered not by investigator; male body weight ≥50.0 kg, female ≥45.0 kg; 19.0-26.0 kg/m².
  3. Part C (obese adults): BMI 28.0-35.0 kg/m²; body weight stable within 3 months prior to screening (weight change ≤5%). No concomitant diseases interfering with safety, PK or weight evaluation.
  4. Female participants are non-pregnant and non-lactating.
  5. All participants (male and female) agree to use effective from through 6 months after last study drug administration; no plan for pregnancy, sperm / oocyte donation.
  6. For Part C: Able to complete hospitalization for first 10 days, outpatient visits, home drug administration and study diary; refrain from additional weight-loss medications, bariatric surgery or intensive weight-loss programs.
  7. Voluntarily sign written informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. History of severe/uncontrolled cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immune, dermatological, neurological or psychiatric diseases with ongoing clinical significance.
  2. : >450 ms (male) / >470 ms (female).
  3. Recurrent headache/migraine, recurrent nausea/vomiting.
  4. Blood donation ≥400 mL within 3 months before screening.
  5. History of orthostatic hypotension, dysphagia.
  6. Gastrointestinal disorders affecting drug absorption.
  7. Cannot comply with unified diet requirements, lactose intolerance.
  8. Major surgery within 3 months before screening or planned surgery during study.
  9. Known to study drug or placebo .
  10. Alcohol or substance abuse history; positive drug-of-abuse screen or positive alcohol breath test.
  11. Excessive alcohol / tobacco / caffeine intake defined per protocol.
  12. Use of metformin or other biguanides within 3 months before screening; systemic within 1 month before screening; CYP-modifying drugs within 30 days before screening; prescription/OTC/herbal products within 14 days before screening.
  13. Consumption of grapefruit / citrus fruits/juice within 5 days pre-screening and refusal to abstain during study.
  14. Vaccines or biological agents within 4 months pre-screening or planned during study.
  15. Participation in another interventional clinical trial within 3 months before screening.
  16. Difficult venous access, history of needle-phobia.
  17. Acute disease within 14 days prior to screening.
  18. Other conditions judged inappropriate for enrollment by investigator. Additional Exclusion for Part C (obese participants): Fasting glucose ≥11.0 mmol/L or ≥8.0%; secondary obesity, eating disorders, cardiovascular disease, moderate-severe obstructive sleep apnea, active liver disease, significant renal impairment.

Repeated BP: SBP ≥160 mmHg or DBP ≥100 mmHg; /AST >2×; total >1.5×ULN; \<60 mL/min/1.73 m².

Weight-loss drugs, intensive weight-loss program within 3-month pre-screening; prior or planned bariatric surgery.

Terms in these criteria, in plain language(14)

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.

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.

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.

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.

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.

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.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

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.

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.

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.

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.

05

Study design

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

Study arms

  • Experimental
    Part-A-100 mg Cohort

    Drug: IPG1094 Tablet 100 mg,single oral dose, fasted condition;Drug: Matching Placebo Tablet,single oral dose, fasted condition

  • Experimental
    Part-A-300 mg Cohort

    Drug: IPG1094 Tablet 300 mg,single oral dose, fasted condition;Drug: Matching Placebo Tablet,single oral dose, fasted condition

  • Experimental
    Part-B1-50 mg QD Cohort

    Drug: IPG1094 Tablet 50 mg QD, post-meal for 10 days;Drug: Matching Placebo Tablet QD, post-meal for 10 days

  • Experimental
    Part-B2-100 mg QD Cohort

    Drug: IPG1094 Tablet 100 mg QD, post-meal for 10 days;Drug: Matching Placebo Tablet QD, post-meal for 10 days

  • Experimental
    Part-B3-200 mg QD Cohort

    Drug: IPG1094 Tablet 200 mg QD, post-meal for 10 days;Drug: Matching Placebo Tablet QD, post-meal for 10 days

  • Experimental
    Part-B4-100 mg BID Optional Cohort(optional, depends on safety/PK data)

    Drug: IPG1094 Tablet 100 mg BID post-meal;Drug: Matching Placebo Tablet BID post-meal

  • Experimental
    Part-C1-100 mg QD Obese Cohort

    Drug: IPG1094 Tablet 100 mg QD post-meal for 28 days;Drug: Matching Placebo Tablet QD post-meal for 28 days

  • Experimental
    Part-C2-200 mg QD Obese Cohort

    Drug: IPG1094 Tablet 200 mg QD post-meal for 28 days;Drug: Matching Placebo Tablet QD post-meal for 28 days

  • Experimental
    Part-C3-300 mg QD Obese Cohort

    Drug: IPG1094 Tablet 300 mg QD post-meal for 90 days;Drug: Matching Placebo Tablet QD post-meal for 90 days

Interventions

  • DrugIPG1094 Tablet and matching Placebo

    IPG1094 tablet is a macrophage migration inhibitory factor(MIF) modulator tablet; matching placebo identical in appearance, dosage form and number of tablets. Part A: single oral dose under fasting condition. Part B: multiple oral doses after standard meal; B1-B3 QD ×10 d; optional B4: BID ×9 d, morning dose only on Day10. Part C: obese participants take drug after standard breakfast; C1/C2 28-day QD; C3 90-day QD; D-1-D10 in-hospital; subsequent home administration.

06

What researchers measure

Primary outcomes

  1. Part A: Maximum Observed Plasma Concentration (Cmax) of IPG1094 after single dose

    Single-dose maximum observed plasma concentration (Cmax) of IPG1094 following oral administration in healthy adult participants.

    Time frame: Up to 96 hours post-dose

  2. Part A: Time to Maximum Plasma Concentration (Tmax) of IPG1094 after single dose

    Single-dose time to reach maximum plasma concentration (Tmax) of IPG1094 following oral administration in healthy adult participants.

    Time frame: Up to 96 hours post-dose

  3. Part A: Terminal Elimination Half-life (t1/2) of IPG1094 after single dose

    Single-dose terminal elimination half-life (t1/2) of IPG1094 following oral administration in healthy adult participants.

    Time frame: Up to 96 hours post-dose

  4. Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of IPG1094 in Part A

    Single-dose AUC0-t of IPG1094 following oral administration in healthy adult participants.

    Time frame: Up to 96 hours post-dose

  5. Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of IPG1094 in Part A

    Single-dose AUC0-inf of IPG1094 following oral administration in healthy adult participants.

    Time frame: Up to 96 hours post-dose

  6. Part A: Apparent Oral Clearance (CL/F) of IPG1094 in Part A

    Single-dose apparent oral clearance (CL/F) of IPG1094 following oral administration in healthy adult participants.

    Time frame: Up to 96 hours post-dose

  7. Steady-State Maximum Observed Plasma Concentration (Css,max) of IPG1094 in Part B

    Multiple-dose steady-state maximum observed plasma concentration (Css,max) of IPG1094 after repeated oral dosing in healthy adult participants.

    Time frame: Day 1 to Day 13

  8. Time to Steady-State Maximum Plasma Concentration (Tss,max) of IPG1094 in Part B

    Multiple-dose time to steady-state maximum plasma concentration (Tss,max) of IPG1094 after repeated oral dosing in healthy adult participants.

    Time frame: Day 1 to Day 13

  9. Area Under the Plasma Concentration-Time Curve Over One Dosing Interval at Steady State (AUC0-τ) of IPG1094 in Part B

    Multiple-dose steady-state AUC0-τ of IPG1094 after repeated oral dosing in healthy adult participants.

    Time frame: Day 1 to Day 13

  10. Steady-State Apparent Oral Clearance (CLss/F) of IPG1094 in Part B

    Multiple-dose steady-state apparent oral clearance (CLss/F) of IPG1094 after repeated oral dosing in healthy adult participants.

    Time frame: Day 1 to Day 13

  11. Accumulation Index Based on AUC (Rac,AUC) of IPG1094 in Part B

    Accumulation index calculated using AUC (Rac,AUC) of IPG1094 after repeated oral dosing in healthy adult participants.

    Time frame: Day 1 to Day 13

  12. Accumulation Index Based on Cmax (Rac,Cmax) of IPG1094 in Part B

    Accumulation index calculated using Cmax(Rac,Cmax) of IPG1094 after repeated oral dosing in healthy adult participants.

    Time frame: Day 1 to Day 13

  13. Safety indicators:adverse event

    Time frame: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group

Secondary outcomes

  1. Part A: Safety indicators:adverse event

    Time frame: Up to 8-day follow-up

  2. Part B: Safety indicators:adverse event

    Time frame: Up to Day16 follow-up

  3. Part C: Percentage change from baseline in body weight on Day 30 for the 100 mg QD and 200 mg QD cohorts

    Time frame: Day30 for 100/200 mg QD groups

  4. Part C: Percentage change from baseline in body weight on Day 90 for the 300 mg QD cohort.

    Time frame: Day90 for 300 mg QD group

  5. Part C: Changes from baseline in body weight (kg) across all scheduled visits

    Time frame: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group

  6. Part C: Changes from baseline BMI across all scheduled visits

    Time frame: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group

  7. Part C: Changes from baseline waist circumference across all scheduled visits

    Time frame: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group

  8. Part C: proportion of subjects achieving ≥5% weight loss from baseline at the endpoint assessment.

    Time frame: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group

  9. Part C: Cmax following first and last dosing.

    Time frame: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group

  10. Part C: Tmax following first and last dosing.

    Time frame: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group

  11. Part C: AUC₀-τ following the first dose and last dose

    Time frame: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group

  12. Part C: Accumulation index

    Time frame: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.

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.

Registered
Oct 28, 2026
First posted
Nov 13, 2026
StartEst.
Nov 25, 2026
Primary completionEst.
Jun 25, 2027
CompletionEst.
Aug 25, 2027
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07935291
Lead sponsor
Nanjing Immunophage Biotech Co., Ltd
Collaborators
Zhejiang Hospital
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Nov 25, 2026 (estimated)
Primary completion
Jun 25, 2027 (estimated)
Completion
Aug 25, 2027 (estimated)
Last update
Nov 13, 2026

Study contacts

qiaofeng qu
Contact
qfqu@immunophage.com.cn
+86 021-34782827

Oversight

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

Not currently enrolling

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Discussion

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