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

Hanmi Pharmaceutical

Status and phase: Active, not recruiting; Phase 3

Conditions: Obesity

Treatments: Drug: Placebo; Drug: HM11260C

Study type: Interventional

Funder types: Industry

Identifiers

NCT06174779

HM-EXC-301

Details and patient eligibility

About

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

Enrollment: 420 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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420 participants in 2 patient groups, including a placebo group

HM11260C

Experimental group

Description:

Weekly administration by subcutaneous injection

Treatment:

Drug: HM11260C

Placebo

Placebo Comparator group

Description:

Weekly administration by subcutaneous injection

Treatment:

Drug: Placebo