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

June 9, 2026 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
349

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100010
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Semaglutide
Drug: 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 24 weeks.
Experimental: IBI362
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥10% weight loss
Time Frame: Week 32
Week 32

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥15% weight loss
Time Frame: Week 32
Week 32
Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥5% weight loss
Time Frame: Week 32
Week 32
Proportion of subjects who achieve composite endpoint of HbA1c<6.5% and ≥5%, ≥10% or ≥15% weight loss
Time Frame: Week 32
Week 32
Change from Baseline in HbA1c
Time Frame: Week 32
Week 32
Change in fasting plasma glucose(FPG) from baseline
Time Frame: Week 32
Week 32
Change in 7-point self-monitored blood glucose(SMBG) from baseline
Time Frame: Week 32
Week 32
Proportion of subjects achieving HbA1c < 7.0%, ≤ 6.5%, and < 5.7%
Time Frame: Week 32
Week 32
Change in body weight from baseline
Time Frame: Week 32
Week 32
Percent change in body weight from baseline
Time Frame: Week 32
Week 32
Change in waist circumference from baseline
Time Frame: Week 32
Week 32
Change in body mass index (BMI) from baseline
Time Frame: Week 32
Week 32
Proportion of subjects achieving weight loss of ≥ 5%, ≥ 10%, or ≥ 15%
Time Frame: Week 32
Week 32
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
Week 32
Change in systolic blood pressure(SBP) and diastolic blood pressure(DBP) from baseline
Time Frame: Week 32
Week 32
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
Week 32
Changes in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) from baseline
Time Frame: Week 32
Week 32
Change in serum uric acid from baseline
Time Frame: Week 32
Week 32
Change in quality of life (IWQoL-Lite-CT) from baseline
Time Frame: Week 32
Week 32
Change in quality of life (SF-36 v2) from baseline
Time Frame: Week 32
Week 32
Change in HOMA2-β from baseline
Time Frame: Week 32
Week 32
Change in HOMA2-IR from baseline
Time Frame: Week 32
Week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 17, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 9, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIBI362A303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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