DelfaGLP-1 Atlas

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Active not recruitingPhase 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)

Assets

Mazdutide / Semaglutide

Listed sites

1

Recruiting sites

—

Enrollment

349

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥28•HbA1c ≤9.5%

Primary endpoint

•Proportion of subjects who achieve composite endpoint of HbA1c <7.0% (HbA1c <7.0% achievement, ≥10% weight-loss responders)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06184568
Org study IDCIBI362A303

Timeline

Milestones

Study first posted2023-12-28actual
Study start2024-02-29actual
Primary completion2025-09-17actual
Last update posted2026-02-18actual
Study completion2026-06-30estimated

Assets

Investigational agents

MazdutideSemaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (22)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
10
Weight & body composition
6
Cardiometabolic biomarkers
2
Patient-reported / QoL
2
MASH / liver
1
Other (unclassified)
1

Weight & body composition

6 endpoints
Secondary/protocol endpoint

Change in body weight from baseline

Time frame:Week 32

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percent change in body weight from baseline

Time frame:Week 32

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference from baseline

Time frame:Week 32

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in body mass index (BMI) from baseline

Time frame:Week 32

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Week 32

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

threshold achievement, improvement

Glycemic / diabetes

10 endpoints
Primary/protocol endpoint/low confidence

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

Time frame:Week 32

threshold achievement, improvement

componentsHbA1c <7.0% achievement, ≥10% weight-loss responders

Secondary/protocol endpoint

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

Time frame:Week 32

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, ≥15% weight-loss responders

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:Week 32

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, ≥5% weight-loss responders

Secondary/protocol endpoint

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

Time frame:Week 32

threshold achievement, improvement

componentsHbA1c <6.5% achievement, ≥5% weight-loss responders, ≥10% weight-loss responders, ≥15% weight-loss responders

Secondary/protocol endpoint

Change from Baseline in HbA1c

Time frame:Week 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose(FPG) from baseline

Time frame:Week 32

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

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

Time frame:Week 32

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Week 32

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HOMA2-β from baseline

Time frame:Week 32

change from baseline, improvement

Secondary/protocol endpoint

Change in HOMA2-IR from baseline

Time frame:Week 32

HOMA-IR (insulin sensitivity)

change from baseline, improvement

MASH / liver

1 endpoint
Secondary/protocol endpoint

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

Time frame:Week 32

change from baseline, improvement

componentsALT, change, AST, change

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

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

Time frame:Week 32

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

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

change from baseline, improvement

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

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

Time frame:Week 32

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Week 32

SF-36 total

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change in serum uric acid from baseline

Time frame:Week 32

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.