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

Innovent Biologics

Status and phase

Active, not recruiting

Phase 3

Conditions

Obesity

Type 2 Diabetes

Treatments

Drug: IBI362

Drug: Semaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT06184568

CIBI362A303

Details and patient eligibility

About

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.

Enrollment

349 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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