OverweightPhase 1NCT07802899
An Exploratory Study of Single-Dose and Multiple-Doses IBI3042 in Healthy, Overweight, or Obese Participants
A Phase 1 study testing IBI3042 in people with Overweight and Obesity, run by Hongwei Jiang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Heathy Participants
- What is being tested?
- IBI3042
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2026to 2 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Hennan
Caie Wang, +86-0379-64830815, 245454618@qq.com
About this study
Official title: 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.
- Conditions
- Overweight, Obesity, Heathy Participants
- Being tested
- IBI3042, Placebo
- Keywords
- Pharmacokinetics, Pharmacodynamics, Safety and Tolerability, IBI3042
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI3042Drug
IBI3042 is an investigational oral drug administered as single or multiple doses according to the study protocol.
PlaceboDrug
Matching oral placebo is administered as single or multiple doses according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| IBI3042 treatment Group | Experimental | Not described Receives: Drug: IBI3042 |
| Placebo Control Group | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (Part A)
Measured: Through study completion, an average of 29 days.
Number of Participants With Abnormal Physical Examination Findings (Part A)
Measured: Through study completion, an average of 29 days.
Number of Participants With Clinically Significant Abnormal Vital Signs (Part A)
Measured: Through study completion, an average of 29 days.
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part A)
Measured: Through study completion, an average of 29 days.
Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part A)
Measured: Through study completion, an average of 29 days.
Number of Participants With Adverse Events (Part B)
Measured: Through study completion, an average of 57 days.
Number of Participants With Abnormal Physical Examination Findings (Part B)
Measured: Through study completion, an average of 57 days.
Number of Participants With Clinically Significant Abnormal Vital Signs (Part B)
Measured: Through study completion, an average of 57 days.
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part B)
Measured: Through study completion, an average of 57 days.
Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part B)
Measured: Through study completion, an average of 57 days.
Secondary outcomes (18)
Area under the blood concentration-time curve (AUC) (Part A)
Measured: Through study completion, an average of 29 days.
Peak Plasma Concentration (Cmax) (Part A)
Measured: Through study completion, an average of 29 days.
Time to Reach Peak Plasma Concentration (Tmax) (Part A)
Measured: Through study completion, an average of 29 days.
Apparent Clearance (CL/F) (Part A)
Measured: Through study completion, an average of 29 days.
Apparent Volume of Distribution (Vz/F) (Part A)
Measured: Through study completion, an average of 29 days.
Terminal Half-Life (T1/2) (Part A)
Measured: Through study completion, an average of 29 days.
Area Under the Plasma Concentration-Time Curve (AUC) (Part B)
Measured: Through study completion, an average of 57 days.
Peak Plasma Concentration (Cmax) (Part B)
Measured: Through study completion, an average of 57 days.
Time to Reach Peak Plasma Concentration (Tmax) (Part B)
Measured: Through study completion, an average of 57 days.
Apparent Clearance (CL/F) (Part B)
Measured: Through study completion, an average of 57 days.
Apparent Volume of Distribution (Vz/F) (Part B)
Measured: Through study completion, an average of 57 days.
Terminal Half-Life (T1/2) (Part B)
Measured: Through study completion, an average of 57 days.
Changes in body weight from baseline (Part B)
Measured: Through study completion, an average of 57 days.
Percentage change in body weight from baseline (Part B)
Measured: Through study completion, an average of 57 days.
Percentage change in waist circumference from baseline (Part B)
Measured: Through study completion, an average of 57 days.
Percentage change in body mass index (BMI) from baseline (Part B)
Measured: Through study completion, an average of 57 days.
Body Mass Index (BMI) change from baseline (Part B)
Measured: Through study completion, an average of 57 days.
Changes in waist circumference from baseline (Part B)
Measured: Through study completion, an average of 57 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start2 Sep 2026 (estimated)
- Primary completion20 Mar 2027 (estimated)
- Study completion2 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential group-assignment design, including single ascending dose (SAD) phase and multiple ascending dose (MAD) phase. Cohort A0 receives IBI3042 in a non-randomized manner. Participants in other cohorts are randomized to receive IBI3042 or matching placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongwei Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hongwei Jiang, Henan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802899
- Sponsor's protocol ID
- CIBI3042T001
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07802899
- Acronym / sponsor ID
- CIBI3042T001
- Conditions
- Overweight, Obesity, Heathy Participants
- Keywords
- Pharmacokinetics, Pharmacodynamics, Safety and Tolerability, IBI3042
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Hongwei JiangUniversity, hospital or other
- Study start
- 2 Sep 2026 (estimated)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 2 May 2027 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Sequential group-assignment design, including single ascending dose (SAD) phase and multiple ascending dose (MAD) phase. Cohort A0 receives IBI3042 in a non-randomized manner. Participants in other cohorts are randomized to receive IBI3042 or matching placebo.
| Arm | Type | Receives |
|---|---|---|
| IBI3042 treatment Group | Experimental | Drug: IBI3042 |
| Placebo Control Group | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI3042IBI3042 is an investigational oral drug administered as single or multiple doses according to the study protocol. | Drug | IBI3042 treatment Group |
| PlaceboMatching oral placebo is administered as single or multiple doses according to the study protocol. | Drug | Placebo Control Group |
Primary outcome
Number of Participants With Adverse Events (Part A)
Time frame: 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.
Number of Participants With Clinically Significant Abnormal Vital Signs (Part A)
Time frame: 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.
Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part A)
Time frame: 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.
Number of Participants With Abnormal Physical Examination Findings (Part B)
Time frame: 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.
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part B)
Time frame: 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.
18 secondary outcomes
Area under the blood concentration-time curve (AUC) (Part A)
Time frame: Through study completion, an average of 29 days.
Peak Plasma Concentration (Cmax) (Part A)
Time frame: 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.
Apparent Clearance (CL/F) (Part A)
Time frame: 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.
Terminal Half-Life (T1/2) (Part A)
Time frame: 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.
Peak Plasma Concentration (Cmax) (Part B)
Time frame: 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.
Apparent Clearance (CL/F) (Part B)
Time frame: 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.
Terminal Half-Life (T1/2) (Part B)
Time frame: 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.
Percentage change in body weight from baseline (Part B)
Time frame: 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.
Percentage change in body mass index (BMI) from baseline (Part B)
Time frame: 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.
Changes in waist circumference from baseline (Part B)
Time frame: Through study completion, an average of 57 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI3042 in people with Overweight and Obesity, run by Hongwei Jiang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongwei Jiang (+86-0379-64830815, jianghw@haust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (Part A) (time frame: Through study completion, an average of 29 days.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.