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

Hangzhou Zhongmei Huadong Pharmaceutical

Status and phase: Not yet enrolling; Phase 3

Conditions: Overweight and Obesity

Treatments: Drug: HDM1002 placebo, oral, once daily, 52 weeks; Drug: HDM1002 400mg, oral, once daily, 52 weeks; Drug: HDM1002 200mg, oral, once daily, 52 weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT06885021

HDM1002-301

Details and patient eligibility

About

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

Enrollment: 780 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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780 participants in 3 patient groups, including a placebo group

HDM1002 tablets 200mg once daily

Experimental group

Description:

HDM1002 200mg, oral, once daily, 52weeks

Treatment:

Drug: HDM1002 200mg, oral, once daily, 52 weeks

HDM1002 tablets 400mg once daily

Experimental group

Description:

HDM1002 400mg, oral, once daily, 52weeks

Treatment:

Drug: HDM1002 400mg, oral, once daily, 52 weeks

Placebo

Placebo Comparator group

Description:

HDM1002 placebo, oral, once daily, 52weeks

Treatment:

Drug: HDM1002 placebo, oral, once daily, 52 weeks