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

NCT06174779 | Active Not Recruiting Phase 3

• 1 other identifier: HM-EXC-301
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• The percent change of body weight from baseline

  baseline, 40 weeks

• The proportion of subjects achieving body weight loss ≥ 5% from baseline

  baseline, 40 weeks

Secondary Outcomes (10)

• The percent change of body weight from baseline

  baseline, 24 weeks, 64 weeks

• The proportion of subjects achieving body weight loss ≥ 5% from baseline

  baseline, 24 weeks, 64 weeks

• The proportion of subjects achieving body weight loss ≥ 10% from baseline

  baseline, 24 weeks, 40 weeks, 64 weeks

• Change of body weight from baseline

  baseline, 24 weeks, 40 weeks, 64 weeks

• Change of BMI from baseline

  baseline, 24 weeks, 40 weeks, 64 weeks

Study Arms (2)

HM11260C

EXPERIMENTAL

Weekly administration by subcutaneous injection

Drug: HM11260C

Placebo

PLACEBO COMPARATOR

Weekly administration by subcutaneous injection

Drug: Placebo

Interventions

HM11260C DRUG

Test drug

HM11260C

Placebo DRUG

Placebo drug

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with following criteria :
• BMI ≥ 30 kg/m2 or
• kg/m2 ≤ BMI \< 30 kg/m2 with more than one risk factors or comorbidities(hypertension, dyslipidemia, sleep apnea, cardiocerebrovascular disease)
• A person who have failed at least once to weight control using diet and exercise therapy before screening visit.

You may not qualify if:

• A person whose weight change exceeds 5kg within 3 months prior to screening visit.
• Diabetes mellitus (Type 1, type 2, etc.) or HbA1c ≥ 6.5 %.
• Administration of hypoglycemic agents.
• Administration of medicines inducing weight gain.
• Prader-Willi Syndrome or MC4R deficiency.
• Cushing's Syndrome.
• Administration of medicines for weight management.
• 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.
• Administration of Steroids for the systemic use.
• Clinically significant gastric emptying abnormalities.
• History(including family history) of medullary thyroid carcinoma or multiple endocrine adenomatosis.
• History of acute or chronic pancreatitis.
• A person who has the following clinical laboratory test results :
• TSH \< 0.4 mIU/L or TSH \> 6 mIU/L
• Calcitonin \> 100 ng/L

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Kangbuk samsung hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: January 3, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)