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

Recruitment & Eligibility

Status: RECRUITING

Sex: All

Target Recruitment: 420

Inclusion Criteria

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)
A person who have failed at least once to weight control using diet and exercise therapy before screening visit.

Exclusion Criteria

A person whose weight change exceeds 5kg within 3 months prior to screening visit.
Diabetes mellitus (Type 1, type 2, etc.) or HbA1c ≥ 6.5 %.
Administration of hypoglycemic agents.
Administration of medicines inducing weight gain.
Prader-Willi Syndrome or MC4R deficiency.
Cushing's Syndrome.
Administration of medicines for weight management.
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.
Administration of Steroids for the systemic use.
Clinically significant gastric emptying abnormalities.
History(including family history) of medullary thyroid carcinoma or multiple endocrine adenomatosis.
History of acute or chronic pancreatitis.
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
Severe liver disease (AST or AST > 3 x UNL or Total bilirubin > 1.5 x UNL).
Severe renal disease ( eGFR < 30mL/min/1.73m 2 ).
QTc > 450 ms.
Answered 'yes' to question 4 or 5 of the suicidal ideation domain in C-SSRS or history of suicide attempt.
PHQ-9 ≥ 15 or history of depression, anxiety, and other severe Mental illness.
History of alcohol addiction or drug abuse.
History of malignant tumors.
History of severe heart disease or severe neurovascular disease.
Hypersensitivity to investigational products or multi-drug allergy.
Positive to pregnancy test, nursing mother, intention on pregnancy.
Considered by investigator as not appropriate to participate in the clinical study with other reason.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Weekly administration by subcutaneous injection
HM11260C	HM11260C	Weekly administration by subcutaneous injection

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change of body weight 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
The proportion of subjects achieving body weight loss ≥ 5% from baseline	baseline, 24 weeks, 64 weeks
The percent change of body weight 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 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 blood pressure 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

Trial Locations

Locations (1): Kangbuk samsung hospital
🇰🇷
Seoul, Korea, Republic of