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Recruiting Phase 3 NCT06893016

Evaluation of RAY1225 in Adult Participants Who Have Obesity or Are Overweight

Trial Parameters

Condition Obesity
Sponsor Guangdong Raynovent Biotech Co., Ltd
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 640
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-06-15
Completion 2026-06-15
Interventions
RAY1225Placebo

Brief Summary

The primary objective of this study is to demonstrate that RAY1225 is superior to placebo for percent change in body weight.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥ 18 years. 2. Body mass index ≥ 28 kg/m2 or ≥24kg/m² to \<28 kg/m2 with at least 1 of the following weight-related comorbidities: a) Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg, or the use of at least one antihypertensive medication to maintain normal blood pressure;b) Fasting triglycerides (TG) ≥1.70 mmol/L, fasting low-density lipoprotein cholesterol (LDL-C) ≥4.1 mmol/L, fasting high-density lipoprotein cholesterol (HDL-C) \<1.04 mmol/L, or the need for at least one lipid-lowering treatment to maintain normal lipid levels; c) Obstructive sleep apnea syndrome; d) Fatty liver; e) Cardiovascular disease; e) Polycystic ovary syndrome. 3. History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise. Exclusion Criteria: 1. Obesity known to be caused by monogenic mutations, other diseases, or medications. 2. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia sy

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