A Phase 1 interventional study of IBI3046 and placebo in Obesity and Overweight, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Innovent Biologics (Suzhou) Co. Ltd. (part of Innovent Biologics, Inc.) · Phase 1, Interventional, and Treatment
This study evaluates the safety, tolerability, pharmacokinetics and pharmacodynamics of IBI3046 in Chinese overweight or obese participants, comprising four phases: single ascending dose (SAD), multiple ascending dose (MAD), IBI3046 administration after mazdutide discontinuation, and IBI3046 in combination with mazdutide
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 128 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 199 studies on the registry; 46 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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.
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.
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.
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.
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.
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.
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.
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.
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.
Subjects receive single-dose matching placebo for IBI3046 in Part1 SAD phase, across 5 corresponding cohorts.
Drug: placebo
All subjects receive active reference drug first, followed by administration of IBI3046 across 2 different dose cohorts, to evaluate safety, tolerability, PK and PD.
Drug: IBI3046
All subjects receive continuous active reference drug. Matching placebo for IBI3046 is administered at corresponding time points across 2 cohorts in Part4 combination phase.
Drug: placebo
All subjects receive continuous active reference drug. IBI3046 is administered at different time points across 2 different dose cohorts, to evaluate safety, tolerability, PK and PD.
Drug: IBI3046
All subjects receive active reference drug first, followed by matching placebo for IBI3046 across 2 corresponding cohorts in Part3 combination phase.
Drug: placebo
Subjects receive matching placebo for IBI3046 in Part2 MAD phase, across 3 corresponding cohorts.
Drug: placebo
Subjects receive multiple ascending repeated doses of IBI3046 across 3 different dose cohorts, to evaluate safety, tolerability and steady-state pharmacokinetics.
Drug: IBI3046
Subjects receive single ascending doses of IBI3046 across 5 different dose cohorts, to evaluate safety, tolerability and pharmacokinetics.
Drug: IBI3046
subcutaneous injection
subcutaneous injection
Number of participants with Adverse Event
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Change in systolic blood pressure after dosing in each dose group(Unit of Measure: mmHg)
Systolic blood pressure will be measured and recorded at each specified time point
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Change in diastolic blood pressure after dosing in each dose group(Unit of Measure: mmHg)
diastolic blood pressure will be measured and recorded at each specified time point
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Number of participants with clinically significant abnormal findings in complete physical examination(Unit of Measure: participants)
A complete physical examination will be performed at each specified time point, including assessment of general appearance, respiratory system, cardiovascular system, abdomen, skin, head and neck (including ears, nose, and throat), lymph nodes, thyroid gland, musculoskeletal system (including spine and extremities), and neurological system. Any finding that is new or worsened from baseline and deemed clinically significant by the investigator will be
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Number of participants with clinically significant changes in physical examination results；
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Number of participants with abnormal ECG changes before and after administration in each dose group
Abnormal changes in ECG heart rate, rhythm, and morphology of each wave segment will be recorded.
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
renal clearance (CLr)
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Immunogenicity characteristics of IBI3046
To characterize the immunogenicity of IBI3046 based on serum sample analysis at prespecified time points as defined in the study protocol.
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Pharmacodynamics (PD) Body weight: change from baseline in body weight. baseline in body weight.
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Area Under the Curve (AUC) of the serum concentration-time profile
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Maximum Concentration (Cmax) of the drug in serum
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
time to maximum concentration (Tmax)
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Elimination Half-life (t1/2)
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Amount of drug excreted in urine (Ae)
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Fraction of dose excreted in urine(Fe)
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Started Sep 2026 (actual). Primary completion is estimated for Jul 2028, 21 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 21 months is above 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.
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 ↗
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