Skip to main content
OpenTrials
Completed

NCT Number: NCT06184568

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100010, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IBI362

Drug

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

Drug

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 24 weeks.

Primary outcomes

  1. Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥10% weight loss

    Time frame: Week 32

Secondary outcomes

  1. Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥15% weight loss

    Time frame: Week 32

  2. Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥5% weight loss

    Time frame: Week 32

  3. Proportion of subjects who achieve composite endpoint of HbA1c<6.5% and ≥5%, ≥10% or ≥15% weight loss

    Time frame: Week 32

  4. Change from Baseline in HbA1c

    Time frame: Week 32

  5. Change in fasting plasma glucose(FPG) from baseline

    Time frame: Week 32

  6. Change in 7-point self-monitored blood glucose(SMBG) from baseline

    Time frame: Week 32

  7. Proportion of subjects achieving HbA1c < 7.0%, ≤ 6.5%, and < 5.7%

    Time frame: Week 32

  8. Change in body weight from baseline

    Time frame: Week 32

  9. Percent change in body weight from baseline

    Time frame: Week 32

  10. Change in waist circumference from baseline

    Time frame: Week 32

  11. Change in body mass index (BMI) from baseline

    Time frame: Week 32

  12. Proportion of subjects achieving weight loss of ≥ 5%, ≥ 10%, or ≥ 15%

    Time frame: Week 32

  13. Proportion of patients achieving 24 kg/m 2≤ BMI < 28 kg/m 2 and 18.5 kg/m 2≤ BMI < 24 kg/m 2

    Time frame: Week 32

  14. Change in systolic blood pressure(SBP) and diastolic blood pressure(DBP) from baseline

    Time frame: Week 32

  15. Change in lipids [total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG)] from baseline

    Time frame: Week 32

  16. Changes in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) from baseline

    Time frame: Week 32

  17. Change in serum uric acid from baseline

    Time frame: Week 32

  18. Change in quality of life (IWQoL-Lite-CT) from baseline

    Time frame: Week 32

  19. Change in quality of life (SF-36 v2) from baseline

    Time frame: Week 32

  20. Change in HOMA2-β from baseline

    Time frame: Week 32

  21. Change in HOMA2-IR from baseline

    Time frame: Week 32

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 28, 2023
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.