Clinical trial
Evaluate the Safety and Efficacy of HDM1002 Tablets in Chinese Overweight and Obese Adults
Opening soon · Phase 3 · 0 countries · Registry ID NCT06885021
Opening soonPhase 3Interventional
What this study is about
A Phase 3 Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionOverweight and Obesity
Full registry 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: 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.
Treatments and study arms
HDM1002 200mg, oral, once daily, 52 weeks
Drug
HDM1002 200mg, oral, once daily, 52 weeks
HDM1002 400mg, oral, once daily, 52 weeks
Drug
HDM1002 400mg, oral, once daily, 52 weeks
HDM1002 placebo, oral, once daily, 52 weeks
Drug
HDM1002 placebo, oral, once daily, 52 weeks
Primary outcomes
Percentage Change From Baseline in Body Weight44weeks
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg,
Percentage Change of Participants Achieving Weight Loss ≥ 5%44weeks
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg
Study locations
0 locations were listed when this page was built. The first 40 are shown.
No public site location was included in this record. Check the original registry for updates.