NCT06184568CompletedPhase 3
A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity
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)
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 349 (actual)
- First submitted
- 14 Dec 2023
- Start date
- 29 Feb 2024
- Primary completion date
- 17 Sept 2025
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06184568
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 349
- From 29 Feb 2024 to the primary completion date, 17 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.