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NCT Number: NCT07809945

A Study of IBI3046 in Participants With Overweight or Obesity

This study evaluates the safety, tolerability, pharmacokinetics and pharmacodynamics of IBI3046 in Chinese overweight or obese participants, comprising four phases: single ascending dose (SAD), multiple ascending dose (MAD), IBI3046 administration after mazdutide discontinuation, and IBI3046 in combination with mazdutide

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 101125, China

Location contact

Ruihua Dong

CONTACT

[email protected]

010-80839386

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1.Aged between 18 and 65 years (inclusive) at the time of informed consent, male or female;
  • 2.At screening, 24 kg/m² ≤ BMI ≤ 40 kg/m²;
  • 3.Body weight change ≤ 5 % within 3 months prior to screening ;
  • 4.Female participants of child bearing potential and male participants whose partners are of child bearing potential must agree to use highly effective contraceptive methods during the study and for 6 months after the last study drug administration. For female participants of child bearing potential, the pregnancy test result must be negative at screening. Female participants shall not breast feed. Male / female participants must be willing to refrain from sperm / oocyte donation during the study and for 6 months after the last study drug administration;
  • 5.Able to understand study procedures and requirements, willing to strictly comply with the clinical trial protocol, and voluntarily sign the informed consent form.

Exclusion criteria

  • 1. Secondary overweight or obesity caused by drugs, genetic or other systemic diseases.
  • 2. Abnormal glucose metabolism, including diabetes history or clinically significant abnormal glycemic indicators at screening.
  • 3. Clinically significant abnormal liver function, hematological parameters, ECG indicators or vital signs at screening.
  • 4. Positive screening results for infectious pathogen markers.
  • 5. Personal or family history of specific thyroid neoplasms or endocrine disorders, or clinically significant abnormal thyroid function and thyroid lesions at screening.
  • 6. History of pancreatitis, severe lipid metabolism disorders, severe hypoglycemia or diabetic ketoacidosis.
  • 7. Presence of untreated or clinically significant systemic organ diseases, mental disorders or suicidal risk.
  • 8. History of malignant tumors (excluding partial skin cancers) within 5 years.
  • 9. Positive screening results for infectious pathogen markers.
  • 10. Personal or family history of specific thyroid neoplasms or endocrine disorders, or clinically significant abnormal thyroid function and thyroid lesions at screening.
  • 11. History of pancreatitis, severe lipid metabolism disorders, severe hypoglycemia or diabetic ketoacidosis.
  • 12. Presence of untreated or clinically significant systemic organ diseases, mental disorders or suicidal risk.
  • 13. History of malignant tumors (excluding partial skin cancers) within 5 years.

Treatment and study plan

IBI3046

Drug

subcutaneous injection

Placebo

Drug

subcutaneous injection

Primary outcomes

  1. Number of participants with Adverse Event

    Time frame: up to Day 169 for SAD;up to Day 225 for MAD

  2. Change in systolic blood pressure after dosing in each dose group(Unit of Measure: mmHg)

    Time frame: up to Day 169 for SAD;up to Day 225 for MAD

    Systolic blood pressure will be measured and recorded at each specified time point

  3. Change in diastolic blood pressure after dosing in each dose group(Unit of Measure: mmHg)

    Time frame: up to Day 169 for SAD;up to Day 225 for MAD

    diastolic blood pressure will be measured and recorded at each specified time point

  4. Number of participants with clinically significant abnormal findings in complete physical examination(Unit of Measure: participants)

    Time frame: up to Day 169 for SAD;up to Day 225 for MAD

    A complete physical examination will be performed at each specified time point, including assessment of general appearance, respiratory system, cardiovascular system, abdomen, skin, head and neck (including ears, nose, and throat), lymph nodes, thyroid gland, musculoskeletal system (including spine and extremities), and neurological system. Any finding that is new or worsened from baseline and deemed clinically significant by the investigator will be

  5. Number of participants with clinically significant changes in physical examination results;

    Time frame: up to Day 169 for SAD;up to Day 225 for MAD

  6. Number of participants with abnormal ECG changes before and after administration in each dose group

    Time frame: up to Day 169 for SAD;up to Day 225 for MAD

    Abnormal changes in ECG heart rate, rhythm, and morphology of each wave segment will be recorded.

Secondary outcomes

  1. renal clearance (CLr)

    Time frame: up to Day 3 for SAD;up to Day 57 for MAD

  2. Immunogenicity characteristics of IBI3046

    Time frame: up to Day 169 for SAD;up to Day 225 for MAD

    To characterize the immunogenicity of IBI3046 based on serum sample analysis at prespecified time points as defined in the study protocol.

  3. Pharmacodynamics (PD) Body weight: change from baseline in body weight. baseline in body weight.

    Time frame: up to Day 169 for SAD;up to Day 225 for MAD

  4. Area Under the Curve (AUC) of the serum concentration-time profile

    Time frame: up to Day 3 for SAD;up to Day 57 for MAD

  5. Maximum Concentration (Cmax) of the drug in serum

    Time frame: up to Day 3 for SAD;up to Day 57 for MAD

  6. time to maximum concentration (Tmax)

    Time frame: up to Day 3 for SAD;up to Day 57 for MAD

  7. Elimination Half-life (t1/2)

    Time frame: up to Day 3 for SAD;up to Day 57 for MAD

  8. Amount of drug excreted in urine (Ae)

    Time frame: up to Day 3 for SAD;up to Day 57 for MAD

  9. Fraction of dose excreted in urine(Fe)

    Time frame: up to Day 3 for SAD;up to Day 57 for MAD

Study contacts

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

baiyi yan

CONTACT

[email protected]

17710042669

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Randomized, Double Blind, Placebo Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of IBI3046 in Chinese Participants With Overweight or Obesity

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 9, 2026
Registry last updated
Sep 9, 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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