Clinical trial NCT06174779: A Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus
Official title: A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2023-12-18
Enrollment: 420
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: The percent change of body weight from baseline
timeFrame: baseline, 40 weeks
measure: The proportion of subjects achieving body weight loss ≥ 5% from baseline
timeFrame: baseline, 40 weeks
Secondary outcomes:
measure: The percent change of body weight from baseline
timeFrame: baseline, 24 weeks, 64 weeks
measure: The proportion of subjects achieving body weight loss ≥ 5% from baseline
timeFrame: baseline, 24 weeks, 64 weeks
measure: The proportion of subjects achieving body weight loss ≥ 10% from baseline
timeFrame: baseline, 24 weeks, 40 weeks, 64 weeks
measure: Change of body weight from baseline
timeFrame: baseline, 24 weeks, 40 weeks, 64 weeks
measure: Change of BMI from baseline
timeFrame: baseline, 24 weeks, 40 weeks, 64 weeks
measure: Change of waist circumference from baseline
timeFrame: baseline, 24 weeks, 40 weeks, 64 weeks
measure: Change of glucose metabolism parameters from baseline
timeFrame: baseline, 24 weeks, 40 weeks, 64 weeks
measure: The percentage change of lipid profile parameters from baseline
timeFrame: baseline, 24 weeks, 40 weeks, 64 weeks
measure: Change of blood pressure from baseline
timeFrame: baseline, 24 weeks, 40 weeks, 64 weeks
measure: Change of IWQoL-Lite-CT(Physical function domain) from baseline
timeFrame: baseline, 24 weeks, 40 weeks, 64 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk samsung hospital
Study officials:
References: