Evaluate the Safety and Efficacy of HDM1002 Tablets in Chinese 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

780 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-28

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06500299

Overweight and Obesity

NOT_YET_RECRUITING PHASE2

HDM1002 Tablets in Chinese Overweight and Obese Adult Subjects

NCT06520540

Glucagon-Like Peptide-1 Receptor Agonists

NOT_YET_RECRUITING PHASE1

Efficacy and Safety of HDM1005 in Chinese Obesity or Overweight Patients Without Diabetes

NCT07279194

Obesity & Overweight

RECRUITING PHASE3

Phase II Clinical Study of HDM1005 Injection in Obese Adults Without Diabetes Mellitus

NCT06886126

Obesity

RECRUITING PHASE2

Phase Ib Clinical Study of HDM1005 Injection

NCT06637020

Overweight and Obesity

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight and Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HDM1002 tablets 200mg once daily

HDM1002 200mg, oral, once daily, 52weeks

Group Type EXPERIMENTAL

HDM1002 200mg, oral, once daily, 52 weeks

Intervention Type DRUG

HDM1002 200mg, oral, once daily, 52 weeks

HDM1002 tablets 400mg once daily

HDM1002 400mg, oral, once daily, 52weeks

Group Type EXPERIMENTAL

HDM1002 400mg, oral, once daily, 52 weeks

Intervention Type DRUG

HDM1002 400mg, oral, once daily, 52 weeks

Placebo

HDM1002 placebo, oral, once daily, 52weeks

Group Type PLACEBO_COMPARATOR

HDM1002 placebo, oral, once daily, 52 weeks

Intervention Type DRUG

HDM1002 placebo, oral, once daily, 52 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HDM1002 200mg, oral, once daily, 52 weeks

Intervention Type DRUG

HDM1002 400mg, oral, once daily, 52 weeks

Intervention Type DRUG

HDM1002 placebo, oral, once daily, 52 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No