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Not yet recruitingNCT07802899Updated Sep 3, 2026

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

A Phase 1 interventional study of IBI3042 and Placebo in Overweight, Obesity and Heathy Participants, sponsored by Hongwei Jiang. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Hongwei Jiang · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Overweight
  • Obesity
  • Heathy Participants

Keywords

  • Pharmacokinetics
  • Pharmacodynamics
  • Safety and Tolerability
  • IBI3042
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
94 participants (estimated)

Study arms

  • Experimental
    IBI3042 treatment Group

    Drug: IBI3042

  • Experimental
    Placebo Control Group

    Drug: Placebo

Interventions

  • DrugIBI3042

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

  • DrugPlacebo

    Matching oral placebo is administered as single or multiple doses according to the study protocol.

05

What researchers measure

Primary outcomes

  1. Number of Participants With Adverse Events (Part A)

    Time frame: Through study completion, an average of 29 days.

  2. Number of Participants With Abnormal Physical Examination Findings (Part A)

    Time frame: Through study completion, an average of 29 days.

  3. Number of Participants With Clinically Significant Abnormal Vital Signs (Part A)

    Time frame: Through study completion, an average of 29 days.

  4. Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part A)

    Time frame: Through study completion, an average of 29 days.

  5. Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part A)

    Time frame: Through study completion, an average of 29 days.

  6. Number of Participants With Adverse Events (Part B)

    Time frame: Through study completion, an average of 57 days.

  7. Number of Participants With Abnormal Physical Examination Findings (Part B)

    Time frame: Through study completion, an average of 57 days.

  8. Number of Participants With Clinically Significant Abnormal Vital Signs (Part B)

    Time frame: Through study completion, an average of 57 days.

  9. Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part B)

    Time frame: Through study completion, an average of 57 days.

  10. Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part B)

    Time frame: Through study completion, an average of 57 days.

Secondary outcomes

  1. Area under the blood concentration-time curve (AUC) (Part A)

    Time frame: Through study completion, an average of 29 days.

  2. Peak Plasma Concentration (Cmax) (Part A)

    Time frame: Through study completion, an average of 29 days.

  3. Time to Reach Peak Plasma Concentration (Tmax) (Part A)

    Time frame: Through study completion, an average of 29 days.

  4. Apparent Clearance (CL/F) (Part A)

    Time frame: Through study completion, an average of 29 days.

  5. Apparent Volume of Distribution (Vz/F) (Part A)

    Time frame: Through study completion, an average of 29 days.

  6. Terminal Half-Life (T1/2) (Part A)

    Time frame: Through study completion, an average of 29 days.

  7. Area Under the Plasma Concentration-Time Curve (AUC) (Part B)

    Time frame: Through study completion, an average of 57 days.

  8. Peak Plasma Concentration (Cmax) (Part B)

    Time frame: Through study completion, an average of 57 days.

  9. Time to Reach Peak Plasma Concentration (Tmax) (Part B)

    Time frame: Through study completion, an average of 57 days.

  10. Apparent Clearance (CL/F) (Part B)

    Time frame: Through study completion, an average of 57 days.

  11. Apparent Volume of Distribution (Vz/F) (Part B)

    Time frame: Through study completion, an average of 57 days.

  12. Terminal Half-Life (T1/2) (Part B)

    Time frame: Through study completion, an average of 57 days.

  13. Changes in body weight from baseline (Part B)

    Time frame: Through study completion, an average of 57 days.

  14. Percentage change in body weight from baseline (Part B)

    Time frame: Through study completion, an average of 57 days.

  15. Percentage change in waist circumference from baseline (Part B)

    Time frame: Through study completion, an average of 57 days.

  16. Percentage change in body mass index (BMI) from baseline (Part B)

    Time frame: Through study completion, an average of 57 days.

  17. Body Mass Index (BMI) change from baseline (Part B)

    Time frame: Through study completion, an average of 57 days.

  18. Changes in waist circumference from baseline (Part B)

    Time frame: Through study completion, an average of 57 days.

06

Study locations

1 site
  • The First Affiliated Hospital of Henan University of Science and Technology
    Luoyang, Hennan, China
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07802899
Lead sponsor
Hongwei Jiang
Responsible party
Hongwei Jiang (Chief Physician, Henan University of Science and Technology) — Sponsor-investigator
First posted
Sep 3, 2026
Start date
Sep 2, 2026 (estimated)
Primary completion
Mar 20, 2027 (estimated)
Completion
May 2, 2027 (estimated)
Last update
Sep 3, 2026

Study contacts

Hongwei Jiang
Contact
jianghw@haust.edu.cn
+86-0379-64830815

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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