Health Trials

IBI3042 Study in Healthy Participants and Overweight or Obese Participants

ConditionsOverweightHealthy ParticipantsObesity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18 to 55 years, inclusive.

For Part A: BMI ≥20 and <30 kg/m² and body weight ≥50 kg.

For Part B: BMI ≥24 and ≤40 kg/m², 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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Orforglipron

    Drug

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

  • Matching Placebo

    Drug

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

  • IBI3042

    Drug

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

Treatment groups

104 Participants
are divided into 5 treatment groups
Group A: Investigational Drug: IBI3042 (Part A)Experimental treatment 1 intervention
Group B: Investigational Drug: IBI3042 (Part B)Experimental treatment 1 intervention
Group C: Matching Placebo (Part B)Placebo comparator 1 intervention
Group D: Orforglipron (Part B)Active comparator 1 intervention
Group E: Matching Placebo (Part A)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants With Adverse Events (Part A)

Number of subjects with Adverse Event

Time frame
through study completion, an average of 29 days
2

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.

Time frame
through study completion, an average of 29 days
3

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.

Time frame
through study completion, an average of 29 day
4

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) .

Time frame
through study completion, an average of 29 days

Secondary outcomes

1

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

Time frame
through study completion,an average of 29 days
2

Peak Plasma Concentration (Cmax) (Part A)

Time frame
through study completion,an average of 29 days
3

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

Time frame
through study completion,an average of 29 days
4

Apparent Clearance (CL/F) (Part A)

Time frame
through study completion,an average of 29 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Innovent Biologics (Suzhou) Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov
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