Loading clinical trials...

ACTIVE_NOT_RECRUITINGPHASE3

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

NCT06174779•Hanmi Pharmaceutical Company Limited

View on ClinicalTrials.gov

Summary

A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in adult obesity patients without diabetes mellitus

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with following criteria :
•* BMI ≥ 30 kg/m2 or
•* 27 kg/m2 ≤ BMI \< 30 kg/m2 with more than one risk factors or comorbidities(hypertension, dyslipidemia, sleep apnea, cardiocerebrovascular disease)
•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.
+17 more criteria

Locations (1)

Kangbuk samsung hospital

Seoul, South Korea

Key Dates

Start Date

January 3, 2024

Primary Completion Date

December 31, 2025

Completion Date

July 31, 2026

Last Updated

June 6, 2025

Enrollment

420

ESTIMATED participants

Conditions

Obesity

Interventions

HM11260C

DRUG

Placebo

DRUG

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

NCT01143454

Metabolic DiseaseObesity+4 more

View study

RECRUITINGNA

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

NCT07472881

MenopausePerimenopause+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus

Inclusion Criteria

Exclusion Criteria

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial

Protein Supplementation Intervention on Body Weight

Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose

iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss