An Exploratory Study of Single-Dose and Multiple-Doses IBI3042 in Healthy, Overweight, or Obese Participants

ConditionsOverweight Obesity Heathy Participants

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-55

SponsorHongwei Jiang

About this trial

The goal of this study is to learn about the safety and tolerability of IBI3042, an investigational oral drug that activates the glucagon-like peptide-1 (GLP-1) receptor. The study will also assess how IBI3042 moves through the body and explore its effects on body weight and related measures. Researchers will evaluate whether single and multiple oral doses of IBI3042 can be administered with acceptable safety and tolerability.

The study has two parts. In Part A, healthy or overweight participants will receive a single oral dose of IBI3042 or placebo. In Part B, overweight or obese participants will receive multiple oral doses of IBI3042 or placebo over 29 days. Participants will be assigned to different dose groups, and dose escalation will be guided by safety, tolerability, and available drug concentration data from earlier groups.

Participants will undergo safety assessments and blood sampling during the study. These assessments will include medical examinations, vital signs, laboratory tests, and electrocardiograms. In Part B, researchers will also assess changes in body weight, body mass index, waist circumference, and other metabolic measures.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18 to 55 years, inclusive.

For Part A: BMI ≥20 and<28 kg/m² and body weight ≥50 kg.

For Part B: BMI ≥24 and ≤40 kg/m², with stable body weight during the 3 months prior to screening.

Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose.

Disqualifiers

Known or suspected hypersensitivity to any component of the study drug or to GLP-1 receptor agonists.

History of diabetes or abnormal glycemic parameters at screening.

Personal or family history of thyroid C-cell carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2A or 2B), or calcitonin ≥20 ng/L at screening.

History of acute or chronic pancreatitis, or clinically significant pancreatic enzyme elevation at screening.

Trial design

Design model

Sequential

Treatments tested in this trial

IBI3042
Drug
IBI3042 is an investigational oral drug administered as single or multiple doses according to the study protocol.
Placebo
Drug
Matching oral placebo is administered as single or multiple doses according to the study protocol.

Treatment groups

94 Participants

are divided into 2 treatment groups

Group A: IBI3042 treatment GroupExperimental treatment 1 intervention

Group B: Placebo Control GroupExperimental treatment 1 intervention