A Study of IBI3046 in Participants With Overweight or Obesity

NCT07809945 | Not Yet Recruiting Phase 1

• 1 other identifier: CIBI3046A101
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity and Overweight

Outcome Measures

Primary Outcomes (6)

• Number of participants with Adverse Event

  up to Day 169 for SAD;up to Day 225 for MAD

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

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

  up to Day 169 for SAD;up to Day 225 for MAD

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

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

  up to Day 169 for SAD;up to Day 225 for MAD

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

  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

  up to Day 169 for SAD;up to Day 225 for MAD

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

  up to Day 169 for SAD;up to Day 225 for MAD

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

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

  up to Day 169 for SAD;up to Day 225 for MAD

Secondary Outcomes (9)

• renal clearance (CLr)

  up to Day 3 for SAD;up to Day 57 for MAD

• Immunogenicity characteristics of IBI3046

  up to Day 169 for SAD;up to Day 225 for MAD

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

  up to Day 169 for SAD;up to Day 225 for MAD

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

  up to Day 3 for SAD;up to Day 57 for MAD

• Maximum Concentration (Cmax) of the drug in serum

  up to Day 3 for SAD;up to Day 57 for MAD

Study Arms (8)

Part1-SAD Placebo Control Group

PLACEBO COMPARATOR

Subjects receive single-dose matching placebo for IBI3046 in Part1 SAD phase, across 5 corresponding cohorts.

Drug: placebo

Part3-Combination Background Drug + IBI3046 Group

EXPERIMENTAL

All subjects receive active reference drug first, followed by administration of IBI3046 across 2 different dose cohorts, to evaluate safety, tolerability, PK and PD.

Drug: IBI3046

Part4-Combination: Continuous Reference Drug with Intermittent Placebo Control Group

PLACEBO COMPARATOR

All subjects receive continuous active reference drug. Matching placebo for IBI3046 is administered at corresponding time points across 2 cohorts in Part4 combination phase.

Drug: placebo

Part4-Combination: Continuous Reference Drug with Intermittent IBI3046 Treatment Group

EXPERIMENTAL

All subjects receive continuous active reference drug. IBI3046 is administered at different time points across 2 different dose cohorts, to evaluate safety, tolerability, PK and PD.

Drug: IBI3046

Part3-Combination: Reference Drug followed by Placebo Control Group

PLACEBO COMPARATOR

All subjects receive active reference drug first, followed by matching placebo for IBI3046 across 2 corresponding cohorts in Part3 combination phase.

Drug: placebo

Part2-MAD Placebo Control Group

PLACEBO COMPARATOR

Subjects receive matching placebo for IBI3046 in Part2 MAD phase, across 3 corresponding cohorts.

Drug: placebo

Part2-MAD IBI3046 Treatment Group

EXPERIMENTAL

Subjects receive multiple ascending repeated doses of IBI3046 across 3 different dose cohorts, to evaluate safety, tolerability and steady-state pharmacokinetics.

Drug: IBI3046

Part1-SAD IBI3046 Treatment Group

EXPERIMENTAL

Subjects receive single ascending doses of IBI3046 across 5 different dose cohorts, to evaluate safety, tolerability and pharmacokinetics.

Drug: IBI3046

Interventions

IBI3046 DRUG

subcutaneous injection

Part1-SAD IBI3046 Treatment Group; Part2-MAD IBI3046 Treatment Group; Part3-Combination Background Drug + IBI3046 Group; Part4-Combination: Continuous Reference Drug with Intermittent IBI3046 Treatment Group

placebo DRUG

subcutaneous injection

Part1-SAD Placebo Control Group; Part2-MAD Placebo Control Group; Part3-Combination: Reference Drug followed by Placebo Control Group; Part4-Combination: Continuous Reference Drug with Intermittent Placebo Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 65 years (inclusive) at the time of informed consent, male or female;
• At screening, 24 kg/m² ≤ BMI ≤ 40 kg/m²;
• Body weight change ≤ 5 % within 3 months prior to screening ;
• 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;
• Able to understand study procedures and requirements, willing to strictly comply with the clinical trial protocol, and voluntarily sign the informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 101125, China

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

baiyi yan

CONTACT

17710042669; baiyi.yan@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): July 16, 2028
• Study Completion (Estimated): October 9, 2028
• Last Updated: September 9, 2026

Record last verified: 2026-09

Locations

CN (1)