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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: Placebo; Drug: HM11260C

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Na Young Kim; Phone Number: 82-2-410-9165; Email: skyko7@hanmi.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HM11260C; Weekly administration by subcutaneous injection	Drug: HM11260C; Test drug
Placebo Comparator: Placebo; Weekly administration by subcutaneous injection	Drug: Placebo; Placebo drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Change of waist circumference from baseline	baseline, 24 weeks, 40 weeks, 64 weeks
Change of glucose metabolism parameters from baseline	baseline, 24 weeks, 40 weeks, 64 weeks
The percentage change of lipid profile parameters from baseline	baseline, 24 weeks, 40 weeks, 64 weeks
Change of blood pressure from baseline	baseline, 24 weeks, 40 weeks, 64 weeks
Change of IWQoL-Lite-CT(Physical function domain) from baseline	baseline, 24 weeks, 40 weeks, 64 weeks

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Estimated): December 19, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Estimated): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Diabetes Mellitus; Obesity
• Other Study ID Numbers: HM-EXC-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No