Evaluating HM11260C for treating obesity in adults without diabetes

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

This study is testing a new medication called HM11260C to see if it can help adults with obesity, who don't have diabetes, lose weight and improve their health.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Hanmi Pharmaceutical Company Limited (industry)
• Locations: 1 site (Seoul)
• Trial ID: NCT06174779 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, phase 3 clinical trial designed to assess the efficacy and safety of HM11260C in adults suffering from obesity who do not have diabetes mellitus. Participants will be randomly assigned to receive either HM11260C or a placebo, with the aim of determining the drug's effectiveness in promoting weight loss and improving related health outcomes. The study will include individuals with a BMI of 30 or higher, or those with a BMI between 27 and 30 who have additional health risks. The trial will monitor participants for safety and efficacy over a defined period.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with a BMI of 30 or higher, or those with a BMI between 27 and 30 who have additional risk factors or comorbidities.

Not a fit: Patients with diabetes mellitus or significant recent weight changes are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for weight management in obese adults without diabetes.

How similar studies have performed: Previous studies have shown promise in similar approaches to obesity treatment, but the specific efficacy of HM11260C is being evaluated for the first time in this context.

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.

Where this trial is running

Seoul

• Kangbuk samsung hospital — Seoul, Korea, Republic of (RECRUITING)

Study contacts

• Study coordinator: Na Young Kim

Conditions: Obesity