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NCT Number: NCT07793019

IBI3042 Study in Healthy Participants and 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.

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Key information

Conditions

Overweight Body Weight Healthy Participants Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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) .

Primary outcomes

  1. Number of Participants With Adverse Events (Part A)

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

    Number of subjects with Adverse Event

  2. 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.

  3. 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.

  4. 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) .

  5. 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).

  6. Number of Participants With Adverse Events (Part B)

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

    Number of subjects with Adverse Event

  7. 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.

  8. 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.

  9. 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).

  10. 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).

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

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

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

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

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

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

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

  8. Peak Plasma Concentration (Cmax) (Part B)

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

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

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

  10. Apparent Clearance (CL/F) (Part B)

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

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

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

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

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

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

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

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

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yating Liu

CONTACT

[email protected]

0512-69566088

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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