Overweight and Obesity
Conditions
Brief summary
A Phase 3 Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults
Interventions
DRUGHDM1002 200mg, oral, once daily, 52 weeks
HDM1002 200mg, oral, once daily, 52 weeks
DRUGHDM1002 400mg, oral, once daily, 52 weeks
HDM1002 400mg, oral, once daily, 52 weeks
DRUGHDM1002 placebo, oral, once daily, 52 weeks
HDM1002 placebo, oral, once daily, 52 weeks
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Body Weight | 44weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change of Participants Achieving Weight Loss ≥ 10% and ≥ 15% | 44weeks | Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg. |
| Change From Baseline in Waist Circumference | 44 weeks, 52 weeks | Waist Circumference was recorded in cm |
| Percentage Change of Participants Achieving Weight Loss ≥ 5% , ≥ 10% and ≥ 15% | 52 weeks | Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg. |
Contacts
Primary ContactJing Liu Jing Liu
Backup ContactWenwen Tu
Outcome results
None listed