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

Obesity Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06174779
• Other study ID #: HM-EXC-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 19, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: December 2023
• Source: Hanmi Pharmaceutical Company Limited
• Contact: Na Young Kim
• Phone: 82-2-410-9165
• Email: skyko7[@]hanmi.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 420
• Est. completion date: July 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity

Intervention

Drug:
• HM11260C
Test drug
• Placebo
Placebo drug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percent change of body weight from baseline		baseline, 40 weeks
Primary	The proportion of subjects achieving body weight loss = 5% from baseline		baseline, 40 weeks
Secondary	The percent change of body weight from baseline		baseline, 24 weeks, 64 weeks
Secondary	The proportion of subjects achieving body weight loss = 5% from baseline		baseline, 24 weeks, 64 weeks
Secondary	The proportion of subjects achieving body weight loss = 10% from baseline		baseline, 24 weeks, 40 weeks, 64 weeks
Secondary	Change of body weight from baseline		baseline, 24 weeks, 40 weeks, 64 weeks
Secondary	Change of BMI from baseline		baseline, 24 weeks, 40 weeks, 64 weeks
Secondary	Change of waist circumference from baseline		baseline, 24 weeks, 40 weeks, 64 weeks
Secondary	Change of glucose metabolism parameters from baseline		baseline, 24 weeks, 40 weeks, 64 weeks
Secondary	The percentage change of lipid profile parameters from baseline		baseline, 24 weeks, 40 weeks, 64 weeks
Secondary	Change of blood pressure from baseline		baseline, 24 weeks, 40 weeks, 64 weeks
Secondary	Change of IWQoL-Lite-CT(Physical function domain) from baseline		baseline, 24 weeks, 40 weeks, 64 weeks