Clinical trial NCT06184568: A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes
Obesity
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-12-28
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥10% weight loss
timeFrame: Week 32
Secondary outcomes:
measure: Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥15% weight loss
timeFrame: Week 32
measure: Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥5% weight loss
timeFrame: Week 32
measure: Proportion of subjects who achieve composite endpoint of HbA1c<6.5% and ≥5%, ≥10% or ≥15% weight loss
timeFrame: Week 32
measure: Change from Baseline in HbA1c
timeFrame: Week 32
measure: Change from Baseline in Fasting Plasma Glucose
timeFrame: Week 32
measure: Proportion of subjects who achieve composite endpoint of HbA1c <7.0%，≤6.5% or <5.7%
timeFrame: Week 32
measure: Percent Change from Baseline in Body Weight
timeFrame: Week 32
measure: Change from Baseline in Waist Circumference
timeFrame: Week 32
measure: Proportion of subjects who achieve ≥5%, ≥10% or ≥15% weight loss
timeFrame: Week 32
measure: Change from Baseline in Blood Pressure(Systolic and Diastolic)
timeFrame: Week 32
measure: Percent Change from Baseline in Triglycerides, Total Cholesterol, LDL-c, HDL-c, non-HDL-c
timeFrame: Week 32
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: