IBI3042 Study in Healthy Participants and Overweight or Obese Participants

NCT07793019 | Not Yet Recruiting Phase 1

• 1 other identifier: CIBI3042A101
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (10)

• Number of Participants With Adverse Events (Part A)

  Number of subjects with Adverse Event

  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.

  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.

  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) .

  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).

  through study completion,an average of 29 days

• Number of Participants With Adverse Events (Part B)

  Number of subjects with Adverse Event

  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.

  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.

  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).

  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).

  through study completion, an average of 113 days

Secondary Outcomes (15)

• Area Under the Plasma Concentration?Time Curve (AUC) (Part A)

  through study completion,an average of 29 days

• Peak Plasma Concentration (Cmax) (Part A)

  through study completion,an average of 29 days

• Time to Reach Peak Plasma Concentration (Tmax) (Part A)

  through study completion,an average of 29 days

• Apparent Clearance (CL/F) (Part A)

  through study completion,an average of 29 days

• Apparent Volume of Distribution (Vz/F) (Part A)

  through study completion,an average of 29 days

Study Arms (5)

Investigational Drug: IBI3042 (Part A)

EXPERIMENTAL

IBI3042,oral. Corresponding dose regimen according to study cohort.

Drug: IBI3042

Investigational Drug: IBI3042 (Part B)

EXPERIMENTAL

IBI3042,oral. Corresponding dose regimen according to study cohort.

Drug: IBI3042

Matching Placebo (Part B)

PLACEBO COMPARATOR

Placebo matching to IBI3042, oral. Corresponding dose regimen according to study cohort.

Drug: Matching Placebo

Orforglipron (Part B)

ACTIVE COMPARATOR

Orforglipron, oral. Corresponding dose regimen according to study cohort.

Drug: Orforglipron

Matching Placebo (Part A)

PLACEBO COMPARATOR

Placebo matching to IBI3042, oral. Corresponding dose regimen according to study cohort.

Drug: Matching Placebo

Interventions

Orforglipron DRUG

Oral, corresponding dose regimen according to study cohort (including Part B) .

Orforglipron (Part B)

Matching Placebo DRUG

Oral, matching to IBI3042, corresponding dose regimen according to study cohort (including Part A, Part B) .

Matching Placebo (Part A); Matching Placebo (Part B)

IBI3042 DRUG

Oral, corresponding dose regimen according to study cohort (including Part A, Part B) .

Investigational Drug: IBI3042 (Part A); Investigational Drug: IBI3042 (Part B)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100009, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

orforglipron

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yating Liu

CONTACT

0512-69566088; yating.liu@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 6, 2027
• Study Completion (Estimated): January 26, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

CN (1)