AzTrials
AzTrials

Type 2 DiabetesPhase 3NCT06184568

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

A Phase 3 study testing IBI362 and Semaglutide in people with Type 2 Diabetes and Obesity, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 for 32 weeks (active-controlled treatment period). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes, Obesity
What is being tested?
IBI362 and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
349 participants
Where
1 siteChina
Study dates
29 Feb 2024to 9 Feb 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100010

Other trials in China

About this study

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)

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.

Being tested
IBI362, Semaglutide
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBI362Drug

    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.

  • SemaglutideDrug

    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.

Study groups in NCT06184568
Study groupRoleWhat they receive
SemaglutideActive comparatorNot described
Receives: Drug: Semaglutide
IBI362ExperimentalNot described
Receives: Drug: IBI362

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Week 32

Secondary outcomes (21)

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

    Measured: Week 32

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

    Measured: Week 32

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

    Measured: Week 32

  4. Change from Baseline in HbA1c

    Measured: Week 32

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

    Measured: Week 32

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

    Measured: Week 32

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

    Measured: Week 32

  8. Change in body weight from baseline

    Measured: Week 32

  9. Percent change in body weight from baseline

    Measured: Week 32

  10. Change in waist circumference from baseline

    Measured: Week 32

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

    Measured: Week 32

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

    Measured: 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

    Measured: Week 32

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

    Measured: 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

    Measured: Week 32

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

    Measured: Week 32

  17. Change in serum uric acid from baseline

    Measured: Week 32

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

    Measured: Week 32

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

    Measured: Week 32

  20. Change in HOMA2-β from baseline

    Measured: Week 32

  21. Change in HOMA2-IR from baseline

    Measured: Week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2023
  2. Study start29 Feb 2024
  3. Primary completion17 Sep 2025
  4. Study completion9 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06184568
Sponsor's protocol ID
CIBI362A303
Status last verified
Jun 2026
First submitted
14 Dec 2023
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IBI362 and Semaglutide in people with Type 2 Diabetes and Obesity, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥10% weight loss (time frame: Week 32). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06184568.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in