DelfaGLP-1 Atlas

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CompletedPhase 3

A Study of IBI362 in Participants With Obesity or Overweight

A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of IBI362 in Chinese Participants With Obesity or Overweight (GLORY-1)

Asset

Mazdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

23

Recruiting sites

—

Enrollment

610

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥28

Primary endpoints

•Body weight, % change•≥5% 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 IDNCT05607680
Org study IDCIBI362B301

Timeline

Milestones

Study first posted2022-11-07actual
Study start2022-11-14actual
Primary completion2023-08-21actual
Study completion2024-04-16actual
Last update posted2024-11-12actual

Assets

Investigational agents

Mazdutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

• Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² and with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, fatty liver, weight bearing joint pain, obesity-related dyspnea or obstructive sleep apnea.

Exclusion criteria

•HbA1c ≥ 6. 5% at screening or previous diagnosis of type 1 or type 2 diabetes;
•Weight change > 5.0% after diet and exercise control for at least 12 weeks before screening;
•Have used or are currently using weight loss drugs within 3 months before screening;
•History of pancreatitis;
•Family or personal history of thyroid C-cell carcinoma or multiple endocrine neoplasia (MEN) 2A or 2B；
•History of moderate to severe depression or severe mental illness;
•Any lifetime history of a suicide attempt

Endpoints (30)

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

Weight & body composition
14
Cardiometabolic biomarkers
7
Glycemic / diabetes
5
MASH / liver
2
Patient-reported / QoL
2

Weight & body composition

14 endpoints
Primary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 32

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Percentage of Participants who Achieve ≥5% Body Weight Reduction

Time frame:Week 32

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants who Achieve ≥10%Body Weight Reduction

Time frame:Week 32,Week 48

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants who Achieve ≥15% Body Weight Reduction

Time frame:Week 32,Week 48

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 32,Week 48

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 48

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants who Achieve ≥5% Body Weight Reduction

Time frame:Week 48

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants who Achieve ≥20% Body Weight Reduction

Time frame:Week 32, Week 48

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Neck Circumference

Time frame:Baseline, Week 32, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Hip Circumference

Time frame:Baseline, Week 32, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Weight

Time frame:Baseline, Week 32, Week 48

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 60

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 32, Week 48

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants with BMI < 24 kg/m2

Time frame:Week 32, Week 48

threshold achievement, improvement

Glycemic / diabetes

5 endpoints
Secondary/protocol endpoint

Change from Baseline in Glycated Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 32, Week 48

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in Fasting Plasma Glucose

Time frame:Baseline, Week 32, Week 48

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Change from Baseline in Fasting Insulin

Time frame:Baseline, Week 32, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Fasting C-peptide

Time frame:Baseline, Week 32, Week 48

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Homeostatic Model Assessment of Insulin Resistance-Insulin Resistance Index (HOMA2-IR)

Time frame:Baseline, Week 32, Week 48

HOMA-IR (insulin sensitivity)

change from baseline, improvement

MASH / liver

2 endpoints
Secondary/protocol endpoint

Change from Baseline in Alanine Aminotransferase

Time frame:Baseline, Week 32, Week 48

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Change from Baseline in Aspartate Aminotransferase

Time frame:Baseline, Week 32, Week 48

AST, change

change from baseline, improvement

LOINC 1920-8

Cardiometabolic biomarkers

7 endpoints
Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure

Time frame:Baseline, Week 32, Week 48

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change from Baseline in Diastolic Blood Pressure

Time frame:Baseline, Week 32, Week 48

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change from Baseline in Triglyceride

Time frame:Baseline, Week 32,Week 48

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change from Baseline in Total Cholesterol

Time frame:Baseline, Week 32, Week 48

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 32, Week 48

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 32, Week 48

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change from Baseline in Serum Uric Acid

Time frame:Baseline, Week 32, Week 48

change from baseline, improvement

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Change from Baseline in IWQoL-Lite-CT Questionnaire Scores

Time frame:Baseline, Week 32, Week 48

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in SF-36v2 Questionnaire Scores

Time frame:Baseline, Week 32, Week 48

SF-36 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.