ClinicalTrials.gg
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.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

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

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Keywords

  • Pharmacokinetics
  • Pharmacodynamics
  • Safety and Tolerability
  • IBI3042
03

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 94 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Hongwei Jiang is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

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 →

04

Who can participate

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

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.

Inclusion criteria

  • Aged 18 to 55 years, inclusive.
  • For Part A: ≥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 and male participants with female partners of childbearing potential must agree to use highly effective during the study and for 90 days after the last dose.
  • Able and willing to comply with study procedures and voluntarily provide written .

Exclusion criteria

Exclusion Criteria:

  • Known or suspected 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 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 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 drug, as applicable.
  • Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the study.
Terms in these criteria, in plain language(8)

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.

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.

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.

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.

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.

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.

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.

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.

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.

05

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

  • 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.

06

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.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: IBI3042

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