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

Phase 3

Not yet recruiting

• Conditions: Obesity
• Interventions: Drug: RAY1225; Drug: Placebo

• Registration Number: NCT06893016
• Lead Sponsor: Guangdong Raynovent Biotech Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Study Start: 2025-06-15
• Primary Completion: 2026-06-15
• Study Completion: 2026-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 640

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 syndrome type 2.
3. 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.
4. A history of organ transplantation (excluding corneal transplant), or being currently prepared to undergo organ transplantation.
5. Plans to quit smoking during the study period
6. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RAY1225 High Dose	RAY1225	Participants will receive RAY1225 high dose subcutaneously (SC) for 52 weeks.
Placebo	Placebo	Participants will receive placebo SC for 52 weeks.
RAY1225 Medium Dose	RAY1225	Participants will receive RAY1225 Medium dose subcutaneously (SC) for 52 weeks.
RAY1225 Low Dose	RAY1225	Participants will receive RAY1225 low dose subcutaneously (SC) for 52 weeks.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Body Weight at Week 52	Baseline and Week 52
Number of Participants who Achieved a ≥ 5% Reduction in Body Weight from Baseline at Week 52	Baseline and Week 52

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Waist Circumference at Week 52	Baseline and Week 52

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China