Status:
ACTIVE_NOT_RECRUITING
A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Type 2 Diabetes
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
349 Patients enrolled
Trial Details
Trial ID
NCT06184568
Start Date
February 29 2024
End Date
June 30 2026
Last Update
November 17 2025
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100010