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

A Multicenter, Randomized, Open-label Phase 3 Study Comparing the Efficacy and Safety of IBI362 Versus Semaglutide in Chinese Participants With Early Type 2 Diabetes and Obesity (DREAMS-3)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Type 2 Diabetes
• Intervention / Treatment: Drug: IBI362; Drug: Semaglutide

• Study Type: Interventional
• Enrollment (Actual): 349
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100010
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Semaglutide	Drug: Semaglutide; 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.
Experimental: IBI362	Drug: IBI362; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥10% weight loss	Week 32

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change in 7-point self-monitored blood glucose(SMBG) from baseline	Week 32
Proportion of subjects achieving HbA1c < 7.0%, ≤ 6.5%, and < 5.7%	Week 32
Change in body weight from baseline	Week 32
Percent change in body weight from baseline	Week 32
Change in waist circumference from baseline	Week 32
Change in body mass index (BMI) from baseline	Week 32
Proportion of subjects achieving weight loss of ≥ 5%, ≥ 10%, or ≥ 15%	Week 32
Proportion of patients achieving 24 kg/m 2≤ BMI < 28 kg/m 2 and 18.5 kg/m 2≤ BMI < 24 kg/m 2	Week 32
Change in systolic blood pressure(SBP) and diastolic blood pressure(DBP) from baseline	Week 32
Change in lipids [total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG)] from baseline	Week 32
Changes in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) from baseline	Week 32
Change in serum uric acid from baseline	Week 32
Change in quality of life (IWQoL-Lite-CT) from baseline	Week 32
Change in quality of life (SF-36 v2) from baseline	Week 32
Change in HOMA2-β from baseline	Week 32
Change in HOMA2-IR from baseline	Week 32

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2024
• Primary Completion (Actual): September 17, 2025
• Study Completion (Actual): February 9, 2026

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 28, 2023

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; semaglutide; mazdutide
• Other Study ID Numbers: CIBI362A303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No