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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HDM1002 100mg BID

HDM1002 tablets 100mg twice daily, 12weeks

Group Type EXPERIMENTAL

HDM1002 100 mg QD

Intervention Type DRUG

HDM1002 tablets 100mg daily, 12weeks

HDM1002 200mg BID

HDM1002 tablets 200mg twice daily, 12weeks

Group Type EXPERIMENTAL

HDM1002 200 mg QD 12weeks

Intervention Type DRUG

HDM1002 tablets 200mg daily, 12weeks

HDM1002 400mg QD

HDM1002 tablets 400mg once daily, 12weeks

Group Type EXPERIMENTAL

HDM1002 400 mg QD 12weeks

Intervention Type DRUG

HDM1002 tablets 400mg daily, 12weeks

placebo

Matching placebo will be provided， 12weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo will be provided

Interventions

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HDM1002 100 mg QD

HDM1002 tablets 100mg daily, 12weeks

Intervention Type DRUG

HDM1002 200 mg QD 12weeks

HDM1002 tablets 200mg daily, 12weeks

Intervention Type DRUG

HDM1002 400 mg QD 12weeks

HDM1002 tablets 400mg daily, 12weeks

Intervention Type DRUG

Placebo

Matching placebo will be provided

Intervention Type DRUG

Other Intervention Names

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HDM1002 HDM1002 HDM1002

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes