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

Hangzhou Zhongmei Huadong Pharmaceutical

Status and phase: Not yet enrolling; Phase 2

Conditions: Overweight and Obesity

Treatments: Drug: HDM1002 100 mg QD; Drug: Placebo; Drug: HDM1002 400 mg QD 12weeks; Drug: HDM1002 200 mg QD 12weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT06500299

HDM1002-201

Details and patient eligibility

About

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.

Full 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 BMI between 24 and 40 will be include. A total of 180 participants will be randomized in a 1:1:1:1 ratio to receive different doses of HDM1002 or placebo. Following the screening period to confirm eligibility up to 2-weeks, the study will consist of a treatment period will be 12 weeks, followed by an approximate 4-week follow-up.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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:

  1. Hypertension
  2. Impaired fasting glucose or impaired glucose tolerance
  3. Dyslipidemia
  4. 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 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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180 participants in 4 patient groups, including a placebo group

HDM1002 100mg BID

Experimental group

Description:

HDM1002 tablets 100mg twice daily, 12weeks

Treatment:

Drug: HDM1002 100 mg QD

HDM1002 200mg BID

Experimental group

Description:

HDM1002 tablets 200mg twice daily, 12weeks

Treatment:

Drug: HDM1002 200 mg QD 12weeks

HDM1002 400mg QD

Experimental group

Description:

HDM1002 tablets 400mg once daily, 12weeks

Treatment:

Drug: HDM1002 400 mg QD 12weeks

placebo

Placebo Comparator group

Description:

Matching placebo will be provided， 12weeks

Treatment:

Drug: Placebo