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

Korábbi kezelés

• A person whose weight change exceeds 5kg within 3 months prior to screening visit.
• Administration of Steroids for the systemic use.
• Hypersensitivity to investigational products or multi-drug allergy.

Más betegség

• Prader-Willi Syndrome or MC4R deficiency.
• Cushing's Syndrome.
• 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.
• History of acute or chronic pancreatitis.
• 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.

Laborértékek

• Diabetes mellitus (Type 1, type 2, etc.) or HbA1c ≥ 6.5 %.
• 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.

Egyéb

• Administration of hypoglycemic agents.
• Administration of medicines inducing weight gain.
• Administration of medicines for weight management.
• Clinically significant gastric emptying abnormalities.
• History(including family history) of medullary thyroid carcinoma or multiple endocrine adenomatosis.
• Positive to pregnancy test, nursing mother, intention on pregnancy.
• Considered by investigator as not appropriate to participate in the clinical study with other reason.

• 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.