Status:
RECRUITING
Evaluation of RAY1225 in Adult Participants Who Have Obesity or Are Overweight
Lead Sponsor:
Guangdong Raynovent Biotech Co., Ltd
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
- Age ≥ 18 years.
- 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.
- History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
Exclusion
- Obesity known to be caused by monogenic mutations, other diseases, or medications.
- Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
- A history of moderate to severe depression at any time in the past or a score of ≥15 on the PHQ-9 questionnaire at screening; a history of bipolar disorder, schizophrenia, or other severe psychiatric disorders.
- A history of organ transplantation (excluding corneal transplant), or being currently prepared to undergo organ transplantation.
- Plans to quit smoking during the study period
- Allergic constitution (allergic to multiple medications or foods), or those known to be allergic to RAY1225, GLP-1 receptor agonists, or GLP-1 related drugs.
Key Trial Info
Start Date :
June 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2026
Estimated Enrollment :
640 Patients enrolled
Trial Details
Trial ID
NCT06893016
Start Date
June 15 2025
End Date
September 15 2026
Last Update
July 17 2025
Active Locations (1)
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1
Peking University People's Hospital
Beijing, China