Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Obesity
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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
- 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
- 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.
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT06174779
Start Date
January 3 2024
End Date
July 31 2026
Last Update
June 6 2025
Active Locations (1)
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1
Kangbuk samsung hospital
Seoul, South Korea