A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity

NCT06184568 | Active Not Recruiting Phase 3

• 1 other identifier: CIBI362A303
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, Open-label Phase 3 clinical study comparing the efficacy and safety of IBI362 6 mg OW versus Semalgutide 1 mg OW in obese(BMI≥28kg/m2) early T2D subjects. Subjects will be randomly assigned to IBI362 6 mg and Semalgutide 1 mg groups for 32 weeks (active-controlled treatment period). In the extension period, participants originally on mazdutide were assigned to continue for an additional 24 weeks with mazdutide 9 mg or 6 mg based on whether they achieved the weight-loss target. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 2-week screening period, a 32-week active-controlled treatment period, a 24 week extension period and a 4-week drug withdrawal safety follow-up period.

Conditions

Type 2 Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥10% weight loss

  Week 32

Secondary Outcomes (21)

• Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥15% weight loss

  Week 32

• Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥5% weight loss

  Week 32

• Proportion of subjects who achieve composite endpoint of HbA1c<6.5% and ≥5%, ≥10% or ≥15% weight loss

  Week 32

• Change from Baseline in HbA1c

  Week 32

• Change in fasting plasma glucose(FPG) from baseline

  Week 32

Study Arms (2)

Semaglutide

ACTIVE COMPARATOR

Drug: Semaglutide

IBI362

EXPERIMENTAL

Drug: IBI362

Interventions

IBI362 DRUG

Once-weekly injections of gradually increased doses of IBI362, subcutaneously (SC)，starting dose is IBI362 2.0 mg, continuous After 4 weeks of administration, increase to IBI362 4.0 mg. After 4 weeks of continuous administration, continue to increase to IBI362.

IBI362

Semaglutide DRUG

Once-weekly injections of gradually increased doses of Semaglutide, subcutaneously (SC)，starting dose is semaglutide 0.25mg, after 4 weeks of continuous administration, increase to semaglutide 0.5mg, after 4 weeks of continuous administration, continue Upgrade to semaglutide 1.0 mg for 24 weeks.

Semaglutide

Eligibility Criteria

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

You may qualify if:

• Male or female, age 18 years or older at the time of signing informed consent
• T2D was diagnosed according to WHO standards in 1999(≤5 years)
• The blood glucose was not well controlled after diet and exercise with/without sable metformin(≥1500mg/day，no more than 2550mg/day) within 3 months before screening, and the local laboratory tested 7.5% ≤ HbA1c ≤9.5% during screening
• Have a BMI ≥28 kg/m2

You may not qualify if:

• Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
• A self-reported change in body weight above 5% within 3 months before screening
• Oral hypoglycemic drugs other metformin have been used within 2 months before screening.
• Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes)
• There are active or untreated malignant tumors within 5 years before screening, or patients are in remission of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery)
• Mental illness existed in the past or at the time of screening, and the researcher thinks it is not suitable to participate in this study
• Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period
• The investigator believes that the subject has any other factors that may affect the efficacy or safety evaluation of this study and is not suitable to participate in this study

Sponsors & Collaborators

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

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

mazdutide; semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 28, 2023
• Study Start: February 29, 2024
• Primary Completion: September 17, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

CN (1)