DelfaGLP-1 Atlas

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CompletedPhase 2

A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI362 in Chinese Overweight and Obese Subjects

Asset

Mazdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

—

Enrollment

328

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥28

Primary endpoint

•Body weight, % 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 IDNCT04904913
Org study IDCIBI362B201

Timeline

Milestones

Study first posted2021-05-27actual
Study start2021-06-08actual
Primary completion2023-03-29actual
Study completion2023-12-06actual
Last update posted2025-11-17actual

Assets

Investigational agents

Mazdutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. The first stage: Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² with at least one of the following comorbidities: hyperphagia, pre-diabetes, hypertension, dyslipidemia, fatty liver disease, weight-bearing joint pain, obesity-induced dyspnea or obstructive sleep apnea syndrome; The second stage: Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²)

2. The weight change of the subjects before and after the introduction period was less than 5.0%

Exclusion criteria

1. Diabetes mellitus

2. Weight change > 5.0% after diet and exercise control for at least 12 weeks before screening

3. Have used or are currently using weight loss drugs within 3 months before screening

4. History of pancreatitis

5. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

6. History of moderate to severe depression，or have a history of serious mental illness

7. Any lifetime history of a suicide attempt

Endpoints (16)

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

Cardiometabolic biomarkers
7
Weight & body composition
6
Glycemic / diabetes
2
Patient-reported / QoL
1

Weight & body composition

6 endpoints
Primary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline ,week 24

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants who Achieve ≥5% Body Weight Reduction

Time frame:Baseline, Week 24

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants who Achieve ≥10% Body Weight Reduction

Time frame:Baseline, Week 24

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Absolute change from Baseline in body weight

Time frame:Baseline, Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 24

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in BMI

Time frame:Baseline, Week 24

BMI, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change from Baseline in HbA1c

Time frame:Baseline, Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in fasting plasma glucose

Time frame:Baseline, Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

7 endpoints
Secondary/protocol endpoint

Change from Baseline in systolic blood pressure

Time frame:Baseline, Week 24

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change from Baseline in diastolic blood pressure

Time frame:Baseline, Week 24

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change from Baseline in total cholesterol

Time frame:Baseline, Week 24

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change from Baseline in low-density lipoprotein cholesterol

Time frame:Baseline, Week 24

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change from Baseline in high-density lipoprotein cholesterol

Time frame:Baseline, Week 24

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change from Baseline in triglyceride

Time frame:Baseline, Week 24

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change from Baseline in serum uric acid

Time frame:Baseline, Week 12, Week 24

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Change from Baseline in IWQoL-Lite-CT questionnaire scores

Time frame:Baseline, Week 24

IWQOL-Lite total

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.