Not yet recruiting NCT06885021
Evaluate the Safety and Efficacy of HDM1002 Tablets in Chinese Overweight and Obese Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HDM1002 200mg, oral, once daily, 52 weeks, HDM1002 400mg, oral, once daily, 52 weeks, HDM1002 placebo, oral, once daily, 52 weeks.
- Who it may be relevant to
- Registry conditions: Overweight and Obesity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
A Phase 3 Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults
Interventions
- Drug HDM1002 200mg, oral, once daily, 52 weeks
HDM1002 200mg, oral, once daily, 52 weeks - Drug HDM1002 400mg, oral, once daily, 52 weeks
HDM1002 400mg, oral, once daily, 52 weeks - Drug HDM1002 placebo, oral, once daily, 52 weeks
HDM1002 placebo, oral, once daily, 52 weeks
Primary outcome measures
- Percentage Change From Baseline in Body Weight [Time frame: 44weeks]
- Percentage Change of Participants Achieving Weight Loss ≥ 5% [Time frame: 44weeks]
Secondary outcome measures (3)
- Percentage Change of Participants Achieving Weight Loss ≥ 10% and ≥ 15% [Time frame: 44weeks]
- Change From Baseline in Waist Circumference [Time frame: 44 weeks, 52 weeks]
- Percentage Change of Participants Achieving Weight Loss ≥ 5% , ≥ 10% and ≥ 15% [Time frame: 52 weeks]
Eligibility criteria
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:
- Hypertension
- Dyslipidemia
- Obstructive sleep apnea syndrome
- MASH
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06885021 · HDM1002-301