OverweightPhase 1NCT07793019
IBI3042 Study in Healthy Participants and Overweight or Obese Participants
A Phase 1 study testing Orforglipron and IBI3042 in people with Overweight and Healthy Participants, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a Phase 1 study of IBI3042, an investigational oral medicine being developed as a potential treatment for overweight and obesity. The study has two parts. Part A will evaluate single doses of IBI3042 in healthy adults. Part B will evaluate repeated doses for 13 weeks in adults with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Healthy Participants, Obesity
- What is being tested?
- Orforglipron and IBI3042
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2026to 26 Jan 2028
- 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 <30 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, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100009
Ying Gao, 13621020878, gaoyingpkufh@bjmu.edu.cn
Xia Zhao, 13701082003, zxyjk@126.com
About this study
Official title: A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of Single-Dose IBI3042 in Healthy Participants and Multiple-Dose IBI3042 in Overweight or Obese Participants
This is a Phase 1 study of IBI3042, an investigational oral medicine being developed as a potential treatment for overweight and obesity. The study has two parts. Part A will evaluate single doses of IBI3042 in healthy adults. Part B will evaluate repeated doses for 13 weeks in adults with overweight or obesity. The main goal is to assess the safety and tolerability of IBI3042. The study will also evaluate how IBI3042 is processed in the body and explore its effects on body weight and other metabolic measures. Some participants will receive placebo, and some Part B groups will also receive orforglipron for comparison.
- Conditions
- Overweight, Healthy Participants, Obesity
- Being tested
- Orforglipron, Matching Placebo, 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.
OrforglipronDrug
Oral, corresponding dose regimen according to study cohort (including Part B) .
Matching PlaceboDrug
Oral, matching to IBI3042, corresponding dose regimen according to study cohort (including Part A, Part B) .
IBI3042Drug
Oral, corresponding dose regimen according to study cohort (including Part A, Part B) .
| Study group | Role | What they receive |
|---|---|---|
| Investigational Drug: IBI3042 (Part A) | Experimental | IBI3042,oral. Corresponding dose regimen according to study cohort. Receives: Drug: IBI3042 |
| Investigational Drug: IBI3042 (Part B) | Experimental | IBI3042,oral. Corresponding dose regimen according to study cohort. Receives: Drug: IBI3042 |
| Matching Placebo (Part B) | Placebo comparator | Placebo matching to IBI3042, oral. Corresponding dose regimen according to study cohort. Receives: Drug: Matching Placebo |
| Orforglipron (Part B) | Active comparator | Orforglipron, oral. Corresponding dose regimen according to study cohort. Receives: Drug: Orforglipron |
| Matching Placebo (Part A) | Placebo comparator | Placebo matching to IBI3042, oral. Corresponding dose regimen according to study cohort. Receives: Drug: Matching 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)
Number of subjects with Adverse Event
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Physical Examination Findings (Part A)
Number of participants with at least one clinically significant abnormal finding in physical examination. Physical examination includes general appearance, respiratory tract, cardiovascular, abdominal, skin, head and neck (ear, eye, nose, throat) , lymph node, thyroid, musculoskeletal (spine and extremities), and neurological assessments. Anogenital examination may be omitted as permitted per protocol.
Measured: through study completion, an average of 29 days
Number of Participants With Clinically Significant Abnormal Vital Signs (Part A)
Number of participants with at least one clinically significant abnormal vital sign，including body temperature, pulse, respiratory rate and blood pressure.
Measured: through study completion, an average of 29 day
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part A)
Number of participants with at least one clinically significant abnormal laboratory finding. Laboratory tests including blood routine, blood Biochemistry (including blood lipids), coagulation routine, urine routine, calcitonin, glycated hemoglobin (HbA1c), infection-related immunology tests, thyroid function tests, pregnancy test, serum follicle-stimulating hormone (FSH) .
Measured: through study completion, an average of 29 days
Number of Participants With Clinically Significant Abnormal Twelve?Lead Electrocardiogram Readings (Part A)
Number of participants with at least one clinically significant abnormal finding on resting 12?lead electrocardiogram (ECG). Participants shall lie supine for at least 5 minutes prior to ECG acquisition and remain supine during ECG recording. Evaluated ECG parameters include RR interval, PR interval, heart rate, QT interval, and QTcF (QTcF=QT/RR^0.33).
Measured: through study completion,an average of 29 days
Number of Participants With Adverse Events (Part B)
Number of subjects with Adverse Event
Measured: through study completion, an average of 113 days
Number of Participants With Abnormal Physical Examination Findings (Part B)
Number of participants with at least one clinically significant abnormal finding in physical examination. Physical examination includes general appearance, respiratory tract, cardiovascular, abdominal, skin, head and neck (ear, eye, nose, throat), lymph node, thyroid, musculoskeletal (spine and extremities), and neurological assessments. Anogenital examination may be omitted as permitted per protocol.
Measured: through study completion, an average of 113 days
Number of Participants With Clinically Significant Abnormal Vital Signs (Part B)
Number of participants with at least one clinically significant abnormal vital sign, including body temperature, pulse, respiratory rate and blood pressure.
Measured: through study completion, an average of 113 days
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part B)
Number of participants with at least one clinically significant abnormal laboratory finding. Laboratory tests include blood routine, blood biochemistry (including blood lipids), coagulation routine, urine routine, calcitonin, glycated hemoglobin (HbA1c), infection?related immunology tests, thyroid function tests, pregnancy test, serum follicle?stimulating hormone (FSH).
Measured: through study completion, an average of 113 days
Number of Participants With Clinically Significant Abnormal Twelve?Lead Electrocardiogram Readings (Part B)
Number of participants with at least one clinically significant abnormal finding on resting 12?lead electrocardiogram (ECG). Participants shall lie supine for at least 5 minutes prior to ECG acquisition and remain supine during ECG recording. Evaluated ECG parameters include RR interval, PR interval, heart rate, QT interval, and QTcF (QTcF=QT/RR^0.33).
Measured: through study completion, an average of 113 days
Secondary outcomes (15)
Area Under the Plasma 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 113 days
Peak Plasma Concentration (Cmax) (Part B)
Measured: through study completion, an average of 113 days
Time to Reach Peak Plasma Concentration (Tmax) (Part B)
Measured: through study completion, an average of 113 days
Apparent Clearance (CL/F) (Part B)
Measured: through study completion, an average of 113 days
Apparent Volume of Distribution (Vz/F) (Part B)
Measured: through study completion, an average of 113 days
Terminal Half-Life (T1/2) (Part B)
Measured: through study completion, an average of 113 days
Absolute and Percent Change From Baseline in Body Weight (Part B)
Measured: through study completion, an average of 113 days
Absolute and Percent Change From Baseline in Body Mass Index (BMI) (Part B)
Measured: through study completion, an average of 113 days
Absolute and Percent Change From Baseline in Waist Circumference (Part B)
Measured: through study completion, an average of 113 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start7 Sep 2026
- Primary completion6 Sep 2027 (estimated)
- Study completion26 Jan 2028 (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.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793019
- Sponsor's protocol ID
- CIBI3042A101
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of Single-Dose IBI3042 in Healthy Participants and Multiple-Dose IBI3042 in Overweight or Obese Participants
- ClinicalTrials.gov ID
- NCT07793019
- Acronym / sponsor ID
- CIBI3042A101
- Conditions
- Overweight, Healthy Participants, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Sep 2026 (actual)
- Primary completion
- 6 Sep 2027 (estimated)
- Study completion
- 26 Jan 2028 (estimated)
- First posted
- 28 Aug 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.
This is a Phase 1 study of IBI3042, an investigational oral medicine being developed as a potential treatment for overweight and obesity. The study has two parts. Part A will evaluate single doses of IBI3042 in healthy adults. Part B will evaluate repeated doses for 13 weeks in adults with overweight or obesity. The main goal is to assess the safety and tolerability of IBI3042. The study will also evaluate how IBI3042 is processed in the body and explore its effects on body weight and other metabolic measures. Some participants will receive placebo, and some Part B groups will also receive orforglipron for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Investigational Drug: IBI3042 (Part A) | Experimental | Drug: IBI3042IBI3042,oral. Corresponding dose regimen according to study cohort. |
| Investigational Drug: IBI3042 (Part B) | Experimental | Drug: IBI3042IBI3042,oral. Corresponding dose regimen according to study cohort. |
| Matching Placebo (Part B) | Placebo comparator | Drug: Matching PlaceboPlacebo matching to IBI3042, oral. Corresponding dose regimen according to study cohort. |
| Orforglipron (Part B) | Active comparator | Drug: OrforglipronOrforglipron, oral. Corresponding dose regimen according to study cohort. |
| Matching Placebo (Part A) | Placebo comparator | Drug: Matching PlaceboPlacebo matching to IBI3042, oral. Corresponding dose regimen according to study cohort. |
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 <30 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 |
|---|---|---|
| OrforglipronOral, corresponding dose regimen according to study cohort (including Part B) . | Drug | Orforglipron (Part B) |
| Matching PlaceboOral, matching to IBI3042, corresponding dose regimen according to study cohort (including Part A, Part B) . | Drug | Matching Placebo (Part A), Matching Placebo (Part B) |
| IBI3042Oral, corresponding dose regimen according to study cohort (including Part A, Part B) . | Drug | Investigational Drug: IBI3042 (Part A), Investigational Drug: IBI3042 (Part B) |
Primary outcome
Number of Participants With Adverse Events (Part A)
Time frame: through study completion, an average of 29 days
Number of subjects with Adverse Event
Number of Participants With Abnormal Physical Examination Findings (Part A)
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in physical examination. Physical examination includes general appearance, respiratory tract, cardiovascular, abdominal, skin, head and neck (ear, eye, nose, throat) , lymph node, thyroid, musculoskeletal (spine and extremities), and neurological assessments. Anogenital examination may be omitted as permitted per protocol.
Number of Participants With Clinically Significant Abnormal Vital Signs (Part A)
Time frame: through study completion, an average of 29 day
Number of participants with at least one clinically significant abnormal vital sign，including body temperature, pulse, respiratory rate and blood pressure.
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 at least one clinically significant abnormal laboratory finding. Laboratory tests including blood routine, blood Biochemistry (including blood lipids), coagulation routine, urine routine, calcitonin, glycated hemoglobin (HbA1c), infection-related immunology tests, thyroid function tests, pregnancy test, serum follicle-stimulating hormone (FSH) .
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 at least one clinically significant abnormal finding on resting 12?lead electrocardiogram (ECG). Participants shall lie supine for at least 5 minutes prior to ECG acquisition and remain supine during ECG recording. Evaluated ECG parameters include RR interval, PR interval, heart rate, QT interval, and QTcF (QTcF=QT/RR^0.33).
Number of Participants With Adverse Events (Part B)
Time frame: through study completion, an average of 113 days
Number of subjects with Adverse Event
Number of Participants With Abnormal Physical Examination Findings (Part B)
Time frame: through study completion, an average of 113 days
Number of participants with at least one clinically significant abnormal finding in physical examination. Physical examination includes general appearance, respiratory tract, cardiovascular, abdominal, skin, head and neck (ear, eye, nose, throat), lymph node, thyroid, musculoskeletal (spine and extremities), and neurological assessments. Anogenital examination may be omitted as permitted per protocol.
Number of Participants With Clinically Significant Abnormal Vital Signs (Part B)
Time frame: through study completion, an average of 113 days
Number of participants with at least one clinically significant abnormal vital sign, including body temperature, pulse, respiratory rate and blood pressure.
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part B)
Time frame: through study completion, an average of 113 days
Number of participants with at least one clinically significant abnormal laboratory finding. Laboratory tests include blood routine, blood biochemistry (including blood lipids), coagulation routine, urine routine, calcitonin, glycated hemoglobin (HbA1c), infection?related immunology tests, thyroid function tests, pregnancy test, serum follicle?stimulating hormone (FSH).
Number of Participants With Clinically Significant Abnormal Twelve?Lead Electrocardiogram Readings (Part B)
Time frame: through study completion, an average of 113 days
Number of participants with at least one clinically significant abnormal finding on resting 12?lead electrocardiogram (ECG). Participants shall lie supine for at least 5 minutes prior to ECG acquisition and remain supine during ECG recording. Evaluated ECG parameters include RR interval, PR interval, heart rate, QT interval, and QTcF (QTcF=QT/RR^0.33).
15 secondary outcomes
Area Under the Plasma 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 113 days
Peak Plasma Concentration (Cmax) (Part B)
Time frame: through study completion, an average of 113 days
Time to Reach Peak Plasma Concentration (Tmax) (Part B)
Time frame: through study completion, an average of 113 days
Apparent Clearance (CL/F) (Part B)
Time frame: through study completion, an average of 113 days
Apparent Volume of Distribution (Vz/F) (Part B)
Time frame: through study completion, an average of 113 days
Terminal Half-Life (T1/2) (Part B)
Time frame: through study completion, an average of 113 days
Absolute and Percent Change From Baseline in Body Weight (Part B)
Time frame: through study completion, an average of 113 days
Absolute and Percent Change From Baseline in Body Mass Index (BMI) (Part B)
Time frame: through study completion, an average of 113 days
Absolute and Percent Change From Baseline in Waist Circumference (Part B)
Time frame: through study completion, an average of 113 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 11 Sep 2026.
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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 Orforglipron and IBI3042 in people with Overweight and Healthy Participants, run by Innovent Biologics (Suzhou) Co. Ltd. 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: looking for participants now, as of the sponsor's last update on 11 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. Some participants in this study may receive a placebo. 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 Yating Liu (0512-69566088, yating.liu@innoventbio.com), 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 11 Sep 2026.