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The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in Chinese Obese Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects will receive escalated dose of HRS-7535 administered orally |
|
| Group B | Experimental | Subjects will receive escalated dose of HRS-7535 administered orally |
|
| Group C | Experimental | Subjects will receive escalated dose of HRS-7535 administered orally |
|
| Group D | Experimental | Subjects will receive escalated dose of HRS-7535 administered orally |
|
| Group E | Placebo Comparator | Subjects will receive Placebo administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7535;Placebo | Drug | HRS-7535;Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in body weight from baseline at Week 26 | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with weight loss of ≥5%, ≥10%, ≥15% from baseline in body weight at Week 26 and Week 36 | Week 26 and Week 36 | |
| Percent change in body weight from baseline at Week 36 | Week 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital | Beijing | Beijing Municipality | 100039 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42331800 | Derived | Gu W, Zhang L, Li L, Wei D, Li Q, Zong Y, Ye Z, Shu C, Zhong T, Mu Y. HRS-7535, an oral small-molecule GLP-1 receptor agonist, in Chinese adults with obesity without diabetes: a randomized, double-blind, placebo-controlled phase 2 trial. Nat Commun. 2026 Jun 22. doi: 10.1038/s41467-026-73018-y. Online ahead of print. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Drug | Placebo |
|
| Change from baseline in body weight/ waist circumference/ BMI at Week 26 and Week 36 | Week 26 and Week 36 |
| Change from baseline in Systolic blood pressure and diastolic blood pressure at Week 26 and Week 36 | Week 26 and Week 36 |
| Change from baseline in fasting plasma glucoseat Week 26 and Week 36 | Week 26 and Week 36 |
| Change from baseline in fasting serum insulin at Week 26 and Week 36 | Week 26 and Week 36 |
| Change from baseline in HbA1c at Week 26 and Week 36 | Week 26 and Week 36 |
| Change from baseline in total cholesterol (TC) at Week 26 and Week 36 | Week 26 and Week 36 |
| Change from baseline in low density lipoprotein cholesterol (LDL-C) at Week 26 and Week 36 | Week 26 and Week 36 |
| Change from baseline in high Density lipoprotein cholesterol (HDL-C) at Week 26 and Week 3 | Week 26 and Week 3 |
| Change from baseline in triglycerides (TG) at Week 26 and Week 36 | Week 26 and Week 36 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |