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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
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Glycemic / diabetes
4 endpointsHbA1c change from baseline at week 24
Time frame:Baseline, 24 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
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
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
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 endpointsSafety, Incidence and severity of adverse events and correlation with study drug;
Time frame:Baseline to 52 weeks
Treatment-emergent AEs (any)
descriptive
Time to peak plasma concentration (Tmax)
Time frame:Baseline to 52 weeks
Tmax
descriptive
Time to peak plasma concentration (Cmax)
Time frame:Baseline to 52 weeks
Tmax
descriptive
area under curve (AUC)
Time frame:Baseline to 52 weeks
AUC₀–∞
concentration, descriptive
volume distribution (V)
Time frame:Baseline to 52 weeks
descriptive
half-life (half-life, T1/2)
Time frame:Baseline to 52 weeks
Half-life
descriptive
clearance rate (clearance, CL)
Time frame:Baseline to 52 weeks
descriptive
Provenance
Sources
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.