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

Study Overview
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Brief Summary
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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. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 2-week screening period, a 40-week double-blind treatment period, and a 4-week drug withdrawal safety follow-up period

Official Title
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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)

Conditions
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Type 2 Diabetes and Obesity(Chinese Classification Criteria)

Intervention / Treatment
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* Drug: IBI362
* Drug: Semaglutide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Semaglutide<br> | Drug: Semaglutide<br>* Once-weekly injections of gradually increased doses of Semaglutide, subcutaneously (SC)<br>|
| Experimental: IBI362<br> | Drug: IBI362<br>* Once-weekly injections of gradually increased doses of IBI362, subcutaneously (SC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥10% weight loss |  | Week 40 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥15% weight loss |  | Week 40 | 
| Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥5% weight loss |  | Week 40 | 
| Proportion of subjects who achieve composite endpoint of HbA1c<6.5% and ≥5%, ≥10% or ≥15% weight loss |  | Week 40 | 
| Change from Baseline in HbA1c |  | Week 40 | 
| Change from Baseline in Fasting Plasma Glucose |  | Week 40 | 
| Proportion of subjects who achieve composite endpoint of HbA1c <7.0%，≤6.5% or <5.7% |  | Week 40 | 
| Percent Change from Baseline in Body Weight |  | Week 40 | 
| Change from Baseline in Waist Circumference |  | Week 40 | 
| Proportion of subjects who achieve ≥5%, ≥10% or ≥15% weight loss |  | Week 40 | 
| Change from Baseline in Blood Pressure(Systolic and Diastolic) |  | Week 40 | 
| Percent Change from Baseline in Triglycerides, Total Cholesterol, LDL-c, HDL-c, non-HDL-c |  | Week 40 |