A Phase 1 interventional study of Orforglipron and Matching Placebo in Overweight, Healthy Participants and Obesity, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Innovent Biologics (Suzhou) Co. Ltd. (part of Innovent Biologics, Inc.) · Phase 1, Interventional, and Treatment
This is a Phase 1 study of IBI3042, an investigational oral medicine being developed as a potential treatment for overweight and obesity. The study has two parts. Part A will evaluate single doses of IBI3042 in healthy adults. Part B will evaluate repeated doses for 13 weeks in adults with overweight or obesity. The main goal is to assess the safety and tolerability of IBI3042. The study will also evaluate how IBI3042 is processed in the body and explore its effects on body weight and other metabolic measures. Some participants will receive placebo, and some Part B groups will also receive orforglipron for comparison.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 104 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.
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 →
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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 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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
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.
IBI3042,oral. Corresponding dose regimen according to study cohort.
Drug: IBI3042
IBI3042,oral. Corresponding dose regimen according to study cohort.
Drug: IBI3042
Placebo matching to IBI3042, oral. Corresponding dose regimen according to study cohort.
Drug: Matching Placebo
Orforglipron, oral. Corresponding dose regimen according to study cohort.
Drug: Orforglipron
Placebo matching to IBI3042, oral. Corresponding dose regimen according to study cohort.
Drug: Matching Placebo
Oral, corresponding dose regimen according to study cohort (including Part B) .
Oral, matching to IBI3042, corresponding dose regimen according to study cohort (including Part A, Part B) .
Oral, corresponding dose regimen according to study cohort (including Part A, Part B) .
Number of Participants With Adverse Events (Part A)
Number of subjects with Adverse Event
Time frame: through study completion, an average of 29 days
Number of Participants With Abnormal Physical Examination Findings (Part A)
Number of participants with at least one clinically significant abnormal finding in physical examination. Physical examination includes general appearance, respiratory tract, cardiovascular, abdominal, skin, head and neck (ear, eye, nose, throat) , lymph node, thyroid, musculoskeletal (spine and extremities), and neurological assessments. Anogenital examination may be omitted as permitted per protocol.
Time frame: through study completion, an average of 29 days
Number of Participants With Clinically Significant Abnormal Vital Signs (Part A)
Number of participants with at least one clinically significant abnormal vital sign，including body temperature, pulse, respiratory rate and blood pressure.
Time frame: through study completion, an average of 29 day
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part A)
Number of participants with at least one clinically significant abnormal laboratory finding. Laboratory tests including blood routine, blood Biochemistry (including blood lipids), coagulation routine, urine routine, calcitonin, glycated hemoglobin (HbA1c), infection-related immunology tests, thyroid function tests, pregnancy test, serum follicle-stimulating hormone (FSH) .
Time frame: through study completion, an average of 29 days
Number of Participants With Clinically Significant Abnormal Twelve?Lead Electrocardiogram Readings (Part A)
Number of participants with at least one clinically significant abnormal finding on resting 12?lead electrocardiogram (ECG). Participants shall lie supine for at least 5 minutes prior to ECG acquisition and remain supine during ECG recording. Evaluated ECG parameters include RR interval, PR interval, heart rate, QT interval, and QTcF (QTcF=QT/RR\^0.33).
Time frame: through study completion,an average of 29 days
Number of Participants With Adverse Events (Part B)
Number of subjects with Adverse Event
Time frame: through study completion, an average of 113 days
Number of Participants With Abnormal Physical Examination Findings (Part B)
Number of participants with at least one clinically significant abnormal finding in physical examination. Physical examination includes general appearance, respiratory tract, cardiovascular, abdominal, skin, head and neck (ear, eye, nose, throat), lymph node, thyroid, musculoskeletal (spine and extremities), and neurological assessments. Anogenital examination may be omitted as permitted per protocol.
Time frame: through study completion, an average of 113 days
Number of Participants With Clinically Significant Abnormal Vital Signs (Part B)
Number of participants with at least one clinically significant abnormal vital sign, including body temperature, pulse, respiratory rate and blood pressure.
Time frame: through study completion, an average of 113 days
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part B)
Number of participants with at least one clinically significant abnormal laboratory finding. Laboratory tests include blood routine, blood biochemistry (including blood lipids), coagulation routine, urine routine, calcitonin, glycated hemoglobin (HbA1c), infection?related immunology tests, thyroid function tests, pregnancy test, serum follicle?stimulating hormone (FSH).
Time frame: through study completion, an average of 113 days
Number of Participants With Clinically Significant Abnormal Twelve?Lead Electrocardiogram Readings (Part B)
Number of participants with at least one clinically significant abnormal finding on resting 12?lead electrocardiogram (ECG). Participants shall lie supine for at least 5 minutes prior to ECG acquisition and remain supine during ECG recording. Evaluated ECG parameters include RR interval, PR interval, heart rate, QT interval, and QTcF (QTcF=QT/RR\^0.33).
Time frame: through study completion, an average of 113 days
Area Under the Plasma Concentration?Time Curve (AUC) (Part A)
Time frame: through study completion,an average of 29 days
Peak Plasma Concentration (Cmax) (Part A)
Time frame: through study completion,an average of 29 days
Time to Reach Peak Plasma Concentration (Tmax) (Part A)
Time frame: through study completion,an average of 29 days
Apparent Clearance (CL/F) (Part A)
Time frame: through study completion,an average of 29 days
Apparent Volume of Distribution (Vz/F) (Part A)
Time frame: through study completion,an average of 29 days
Terminal Half-Life (T1/2) (Part A)
Time frame: through study completion,an average of 29 days
Area Under the Plasma Concentration?Time Curve (AUC) (Part B)
Time frame: through study completion, an average of 113 days
Peak Plasma Concentration (Cmax) (Part B)
Time frame: through study completion, an average of 113 days
Time to Reach Peak Plasma Concentration (Tmax) (Part B)
Time frame: through study completion, an average of 113 days
Apparent Clearance (CL/F) (Part B)
Time frame: through study completion, an average of 113 days
Apparent Volume of Distribution (Vz/F) (Part B)
Time frame: through study completion, an average of 113 days
Terminal Half-Life (T1/2) (Part B)
Time frame: through study completion, an average of 113 days
Absolute and Percent Change From Baseline in Body Weight (Part B)
Time frame: through study completion, an average of 113 days
Absolute and Percent Change From Baseline in Body Mass Index (BMI) (Part B)
Time frame: through study completion, an average of 113 days
Absolute and Percent Change From Baseline in Waist Circumference (Part B)
Time frame: through study completion, an average of 113 days
Started Sep 2026 (actual). Primary completion is estimated for Sep 2027, 11 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 11 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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: IBI3042
Innovent Biologics (Suzhou) Co. Ltd. →