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A Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus
A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus
Lead sponsor
Asset
Efpeglenatide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
420
estimated
Study population
Obesity / overweight
Key I/E criterion
•BMI ≥30
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Patients with following criteria :
2. A person who have failed at least once to weight control using diet and exercise therapy before screening visit.
Exclusion criteria
1. A person whose weight change exceeds 5kg within 3 months prior to screening visit.
2. Diabetes mellitus (Type 1, type 2, etc.) or HbA1c ≥ 6.5 %.
3. Administration of hypoglycemic agents.
4. Administration of medicines inducing weight gain.
5. Prader-Willi Syndrome or MC4R deficiency.
6. Cushing's Syndrome.
7. Administration of medicines for weight management.
8. A person who has a history of surgery(including device-based therapy) related to obesity or who has a plan during the clinical trial period.
9. Administration of Steroids for the systemic use.
10. Clinically significant gastric emptying abnormalities.
11. History(including family history) of medullary thyroid carcinoma or multiple endocrine adenomatosis.
12. History of acute or chronic pancreatitis.
13. A person who has the following clinical laboratory test results :
14. Severe liver disease (AST or AST > 3 x UNL or Total bilirubin > 1.5 x UNL).
15. Severe renal disease ( eGFR < 30mL/min/1.73m 2 ).
16. QTc > 450 ms.
17. Answered 'yes' to question 4 or 5 of the suicidal ideation domain in C-SSRS or history of suicide attempt.
18. PHQ-9 ≥ 15 or history of depression, anxiety, and other severe Mental illness.
19. History of alcohol addiction or drug abuse.
20. History of malignant tumors.
21. History of severe heart disease or severe neurovascular disease.
22. Hypersensitivity to investigational products or multi-drug allergy.
23. Positive to pregnancy test, nursing mother, intention on pregnancy.
24. Considered by investigator as not appropriate to participate in the clinical study with other reason.
Endpoints (12)
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
8 endpointsThe percent change of body weight from baseline
Time frame:baseline, 40 weeks
Body weight, % change
percent change from baseline, improvement
The proportion of subjects achieving body weight loss ≥ 5% from baseline
Time frame:baseline, 40 weeks
≥5% weight-loss responders
threshold achievement, improvement
The percent change of body weight from baseline
Time frame:baseline, 24 weeks, 64 weeks
Body weight, % change
percent change from baseline, improvement
The proportion of subjects achieving body weight loss ≥ 5% from baseline
Time frame:baseline, 24 weeks, 64 weeks
≥5% weight-loss responders
threshold achievement, improvement
The proportion of subjects achieving body weight loss ≥ 10% from baseline
Time frame:baseline, 24 weeks, 40 weeks, 64 weeks
≥10% weight-loss responders
threshold achievement, improvement
Change of body weight from baseline
Time frame:baseline, 24 weeks, 40 weeks, 64 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Change of BMI from baseline
Time frame:baseline, 24 weeks, 40 weeks, 64 weeks
BMI, change
change from baseline, improvement
Change of waist circumference from baseline
Time frame:baseline, 24 weeks, 40 weeks, 64 weeks
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
1 endpointChange of glucose metabolism parameters from baseline
Time frame:baseline, 24 weeks, 40 weeks, 64 weeks
change from baseline, improvement
Cardiometabolic biomarkers
2 endpointsThe percentage change of lipid profile parameters from baseline
Time frame:baseline, 24 weeks, 40 weeks, 64 weeks
percent change from baseline, improvement
Change of blood pressure from baseline
Time frame:baseline, 24 weeks, 40 weeks, 64 weeks
change from baseline, improvement
Patient-reported / QoL
1 endpointChange of IWQoL-Lite-CT(Physical function domain) from baseline
Time frame:baseline, 24 weeks, 40 weeks, 64 weeks
IWQOL-Lite physical
change from baseline, improvement
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.