Clinical trial
IBI3042 Study in Healthy Participants and Overweight or Obese Participants
Opening soon · Phase 1 · 1 countries · Registry ID NCT07793019
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
Orforglipron
Oral, corresponding dose regimen according to study cohort (including Part B) .
Matching Placebo
Oral, matching to IBI3042, corresponding dose regimen according to study cohort (including Part A, Part B) .
IBI3042
Oral, corresponding dose regimen according to study cohort (including Part A, Part B) .
Primary outcomes
Number of subjects with Adverse Event
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.
Number of participants with at least one clinically significant abnormal vital sign,including body temperature, pulse, respiratory rate and blood pressure.
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) .
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).
Number of subjects with Adverse Event
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.
Number of participants with at least one clinically significant abnormal vital sign, including body temperature, pulse, respiratory rate and blood pressure.
Study locations
1 locations were listed when this page was built. The first 40 are shown.