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

NCT ID: NCT06174779

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-03
• Study Completion Date: 2026-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HM11260C

Weekly administration by subcutaneous injection

Group Type: EXPERIMENTAL

HM11260C

Intervention Type: DRUG

Test drug

Placebo

Weekly administration by subcutaneous injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo drug

Interventions

HM11260C

Test drug

Intervention Type: DRUG

Placebo

Placebo drug

Intervention Type: DRUG

Eligibility Criteria

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.

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 :

• TSH < 0.4 mIU/L or TSH > 6 mIU/L
• Calcitonin > 100 ng/L
• Amylase or Lipase > 3 x UNL

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kangbuk samsung hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HM-EXC-301

Identifier Type: -

Identifier Source: org_study_id