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

August 31, 2026 updated by: Hongwei Jiang

An Exploratory Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Dose IBI3042 in Healthy or Overweight Participants and Multiple-Dose IBI3042 in Overweight or Obese Participants

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hennan
      • Luoyang, Hennan, China
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 18 to 55 years, inclusive.
  • For Part A: BMI ≥20 and<28 kg/m^2 and body weight ≥50 kg.
  • For Part B: BMI ≥24 and ≤40 kg/m^2, 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.
  • Able and willing to comply with study procedures and voluntarily provide written informed consent.

Exclusion Criteria:

  • 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.
  • Use of medications that may significantly affect gastrointestinal motility, appetite, or drug absorption within 3 months prior to screening.
  • Clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that may increase study-related risk or interfere with study assessments.
  • Clinically significant abnormalities in physical examination or laboratory tests at screening.
  • History of malignancy within 5 years, except for basal cell or squamous cell skin cancer.
  • Use of prescription or over-the-counter medications, dietary supplements, or herbal medicines within 2 weeks or 5 half-lives prior to screening, except as permitted by the protocol.
  • Participation in another drug or medical device clinical study within 3 months prior to screening or within 5 half-lives of the investigational drug, as applicable.
  • Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IBI3042 treatment Group
Drug: IBI3042
IBI3042 is an investigational oral drug administered as single or multiple doses according to the study protocol.
Experimental: Placebo Control Group
Drug: Placebo
Matching oral placebo is administered as single or multiple doses according to the study protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Adverse Events (Part A)
Time Frame: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Number of Participants With Abnormal Physical Examination Findings (Part A)
Time Frame: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Number of Participants With Clinically Significant Abnormal Vital Signs (Part A)
Time Frame: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part A)
Time Frame: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part A)
Time Frame: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Number of Participants With Adverse Events (Part B)
Time Frame: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Number of Participants With Abnormal Physical Examination Findings (Part B)
Time Frame: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Number of Participants With Clinically Significant Abnormal Vital Signs (Part B)
Time Frame: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part B)
Time Frame: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part B)
Time Frame: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the blood concentration-time curve (AUC) (Part A)
Time Frame: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Peak Plasma Concentration (Cmax) (Part A)
Time Frame: Through study completion, an average of 29 days.
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.
Through study completion, an average of 29 days.
Apparent Clearance (CL/F) (Part A)
Time Frame: Through study completion, an average of 29 days.
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.
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.
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 57 days.
Through study completion, an average of 57 days.
Peak Plasma Concentration (Cmax) (Part B)
Time Frame: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Time to Reach Peak Plasma Concentration (Tmax) (Part B)
Time Frame: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Apparent Clearance (CL/F) (Part B)
Time Frame: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Apparent Volume of Distribution (Vz/F) (Part B)
Time Frame: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Terminal Half-Life (T1/2) (Part B)
Time Frame: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Changes in body weight from baseline (Part B)
Time Frame: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Percentage change in body weight from baseline (Part B)
Time Frame: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Percentage change in waist circumference from baseline (Part B)
Time Frame: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Percentage change in body mass index (BMI) from baseline (Part B)
Time Frame: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Body Mass Index (BMI) change from baseline (Part B)
Time Frame: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Changes in waist circumference from baseline (Part B)
Time Frame: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hongwei Jiang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 2, 2026

Primary Completion (Estimated)

March 20, 2027

Study Completion (Estimated)

May 2, 2027

Study Registration Dates

First Submitted

August 31, 2026

First Submitted That Met QC Criteria

August 31, 2026

First Posted (Actual)

September 3, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI3042T001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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