Obesity
Conditions
Brief summary
A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in adult obesity patients without diabetes mellitus
Interventions
DRUGHM11260C
Test drug
DRUGPlacebo
Placebo drug
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| 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 |
Countries
South Korea
Outcome results
None listed