Evaluate the Safety and Efficacy of HDM1002 Tablets in Chinese Overweight and Obese Adults

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Chinese Overweight and Obese Adults

A Phase 3 Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults

Inclusion Criteria:

• 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:

  1. Hypertension
  2. Dyslipidemia
  3. Obstructive sleep apnea syndrome
  4. MASH
  5. Pain in the weight-bearing joints

• At least one previous failure to lose weight through lifestyle modification was defined as < 5% weight loss after ≥3 months of lifestyle modification

Exclusion Criteria:

• 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.