Not yet recruitingPhase 1

A Study of IBI3042 in Healthy Adult Participants

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of IBI3042 in Healthy Adult Participants

Lead sponsor

Fortvita Biologics (USA)Inc.

Asset

IBI3042

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI 20-32

Primary endpoints

•Adverse Events•Clinically Significant Abnormal Vital Signs•Clinically Significant Abnormal 12-lead electrocardiogram

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 IDNCT07842393

Org study IDCIBI3042A102

Timeline

Milestones

Study first posted2026-09-25actual

Last update posted2026-09-25actual

Study start2026-09-29estimated

Primary completion2027-02-03estimated

Study completion2027-02-03estimated

Assets

Investigational agents

IBI3042

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Aged 18 to 55 years, inclusive.

•BMI ≥20 and <32 kg/m² and body weight ≥50 kg;

•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, or dietary supplement vitamins within 2 weeks or 5 half-lives, whichever is greater, prior to screening; or use of any herbal products within 4 weeks prior to screening.

•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 (28)

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

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

Number of Participants With Abnormal Glycated Hemoglobin Findings