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

Obesity Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06184568
• Other study ID #: CIBI362A303
• Status: Recruiting
• Phase: Phase 3
• Start date: February 29, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: March 2024
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Linong Ji
• Phone: 13910978815
• Email: jiln[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 342
• Est. completion date: August 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

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.
• 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 32 weeks.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

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