Status:
NOT_YET_RECRUITING
Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults
Lead Sponsor:
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Conditions:
Overweight and Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
It is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety and efficacy of HDM1002 tablets in overweight and obese adults.
Detailed Description
This multicenter, randomized, double-blind, placebo-controlled phase II clinical trial aims to evaluate the safety and efficacy of HDM1002 tablets in overweight and obese adults. Participants with a B...
Eligibility Criteria
Inclusion
- Male or female subjects between 18 and 65 years of age (inclusive).
- BMI≥28 but \< 40.0 kg/m2 at screening or randomization，or BMI≥24.0 kg/m2 but \< 28 kg/m2 with any of the following:
- Hypertension
- Impaired fasting glucose or impaired glucose tolerance
- Dyslipidemia
- Obstructive sleep apnea syndrome
- At least one previous failure to lose weight through lifestyle modification was defined as \< 5% weight loss after ≥3 months of lifestyle modification.
Exclusion
- Weight change ≥5% as reported or documented. Previous diagnosis of type 1, type 2, or any other type of diabetes.
- Diagnosis of overweight or obesity due to other diseases or medications.
- History or family history of medullary thyroid carcinoma, C cell hyperplasia, or multiple endocrine neoplasia type 2.
- Have diseases or conditions that affect gastric emptying or gastrointestinal absorption of nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, chronic pancreatitis, etc. Or a history of acute pancreatitis or acute gallbladder disease within 3 months before signing ICF.
- GLP-1R agonist use within 6 months prior to signing ICF.
- Use of hypoglycemic drugs within 3 months before signing ICF.
Key Trial Info
Start Date :
July 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06500299
Start Date
July 15 2024
End Date
November 30 2024
Last Update
July 15 2024
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