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CompletedPhase 3

A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study (DREAMS-1) to Evaluate the Efficacy and Safety of IBI362 in Chinese Type 2 Diabetes Patients With Poor Glycemia Control Only Through Diet and Exercise

Asset

Mazdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

Enrollment

319

actual

Study population

Type 2 diabetes

Key I/E criterion

HbA1c ≤10.5%

Primary endpoint

HbA1c, change

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 IDNCT05628311
Org study IDCIBI362A301

Timeline

Milestones

Study first posted2022-11-28actual
Study start2023-01-06actual
Primary completion2023-10-25actual
Study completion2024-05-09actual
Last update posted2024-08-20actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. T2D was diagnosed according to WHO standards in 1999 for at least 2 months

2. Age ≥ 18 when signing the informed consent form

3. The blood glucose was not well controlled after simple diet and exercise within 2 months before screening, and the local laboratory tested 7.5% ≤ HbA1c ≤ 10.5% during screening

4. Maintain a stable diet and exercise lifestyle during the study

5. Subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocol

Exclusion criteria

1. Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs

2. Weight change>5% within 12 weeks before screening (chief complaint)

3. Used any oral hypoglycemic drugs within 2 months before screening; ≥ 3 oral hypoglycemic drugs have been used together more than 2 months before screening

4. Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes or gestational diabetes

5. 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)

6. 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

7. Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period

8. 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 (11)

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

Safety / tolerability / PK
7
Glycemic / diabetes
4

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

HbA1c change from baseline at week 24

Time frame:Baseline, 24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of subjects with HbA1c<7.0% at week 24

Time frame:Baseline, 24 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

To assess changes in PD parameters fasting insulin at different time points before and after administration.

Time frame:Baseline to 52 weeks

change from baseline, descriptive

Secondary/protocol endpoint

To assess changes in PD parameters fasting C-peptide at different time points before and after administration.

Time frame:Baseline to 52 weeks

C-peptide AUC

change from baseline, improvement

Safety / tolerability / PK

7 endpoints
Secondary/protocol endpoint

Safety, Incidence and severity of adverse events and correlation with study drug;

Time frame:Baseline to 52 weeks

Treatment-emergent AEs (any)

descriptive

Secondary/protocol endpoint

Time to peak plasma concentration (Tmax)

Time frame:Baseline to 52 weeks

Tmax

descriptive

Secondary/protocol endpoint

Time to peak plasma concentration (Cmax)

Time frame:Baseline to 52 weeks

Tmax

descriptive

Secondary/protocol endpoint

area under curve (AUC)

Time frame:Baseline to 52 weeks

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

volume distribution (V)

Time frame:Baseline to 52 weeks

descriptive

Secondary/protocol endpoint

half-life (half-life, T1/2)

Time frame:Baseline to 52 weeks

Half-life

descriptive

Secondary/protocol endpoint

clearance rate (clearance, CL)

Time frame:Baseline to 52 weeks

descriptive

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.