RecruitingPhase 1

IBI3042 Study in Healthy Participants and Overweight or Obese Participants

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

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Assets

IBI3042 / Orforglipron

Listed sites

Recruiting sites

Estimated enrollment

104

Study population

Healthy volunteers, Obesity / overweight

Eligibility highlights

•BMI 20-30

Primary endpoints

•Adverse Events (Part A)•Abnormal Physical Examination Findings (Part A)•Clinically Significant Abnormal Vital Signs (Part A)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07793019

Org study IDCIBI3042A101

Timeline

Milestones

Study first posted2026-08-28actual

Study start2026-09-07actual

Last update posted2026-09-11actual

Primary completion2027-09-06estimated

Study completion2028-01-26estimated

Assets

Investigational agents

IBI3042 Orforglipron

Who this study enrolls

Healthy volunteersObesity / overweight

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•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.

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.

Endpoints (25)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Absolute and Percent Change From Baseline in Body Weight (Part B)

Time frame:through study completion, an average of 113 days

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute and Percent Change From Baseline in Body Mass Index (BMI) (Part B)

Time frame:through study completion, an average of 113 days

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute and Percent Change From Baseline in Waist Circumference (Part B)

Time frame:through study completion, an average of 113 days

percent change from baseline, improvement

Safety / tolerability / PK

22 endpoints

Primary/protocol endpoint

Number of Participants With Adverse Events (Part A)

Time frame:through study completion, an average of 29 days

event count, event

Primary/protocol endpoint

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

Time frame:through study completion, an average of 29 days

event count, event

Primary/protocol endpoint

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

Time frame:through study completion, an average of 29 day

event count, event

Primary/protocol endpoint

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

Time frame:through study completion, an average of 29 days

event count, event

Primary/protocol endpoint

Number of Participants With Clinically Significant Abnormal Twelve?Lead Electrocardiogram Readings (Part A)

Time frame:through study completion,an average of 29 days

event count, event

Primary/protocol endpoint

Number of Participants With Adverse Events (Part B)

Time frame:through study completion, an average of 113 days

event count, event

Primary/protocol endpoint

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

Time frame:through study completion, an average of 113 days

event count, event

Primary/protocol endpoint

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

Time frame:through study completion, an average of 113 days

event count, event

Primary/protocol endpoint

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

Time frame:through study completion, an average of 113 days

event count, event

Primary/protocol endpoint

Number of Participants With Clinically Significant Abnormal Twelve?Lead Electrocardiogram Readings (Part B)

Time frame:through study completion, an average of 113 days

event count, event

Secondary/protocol endpoint

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

Time frame:through study completion,an average of 29 days

concentration, descriptive

Secondary/protocol endpoint

Peak Plasma Concentration (Cmax) (Part A)

Time frame:through study completion,an average of 29 days

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:through study completion,an average of 29 days

time to event, event

Secondary/protocol endpoint

Apparent Clearance (CL/F) (Part A)

Time frame:through study completion,an average of 29 days

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:through study completion,an average of 29 days

descriptive

Secondary/protocol endpoint

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

Time frame:through study completion,an average of 29 days

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:through study completion, an average of 113 days

concentration, descriptive

Secondary/protocol endpoint

Peak Plasma Concentration (Cmax) (Part B)

Time frame:through study completion, an average of 113 days

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:through study completion, an average of 113 days

time to event, event

Secondary/protocol endpoint

Apparent Clearance (CL/F) (Part B)

Time frame:through study completion, an average of 113 days

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:through study completion, an average of 113 days

descriptive

Secondary/protocol endpoint

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

Time frame:through study completion, an average of 113 days

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.