NCT06885021Not yet recruitingPhase 3
Evaluate the Safety and Efficacy of HDM1002 Tablets in Chinese Overweight and Obese Adults
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
Source: ClinicalTrials.gov · Last updated 19 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
A Phase 3 Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 780 (estimated)
- First submitted
- 13 Mar 2025
- Start date
- 28 Mar 2025
- Primary completion date
- 30 May 2026
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
- Diseases
- Obesity
- NCT number
- NCT06885021
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 780
- From 28 Mar 2025 to the primary completion date, 30 May 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis of type 1, type 2, or any other type of diabetes.
- 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.
Other illness
- 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.
Other
- Weight change ≥5% as reported or documented.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.