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

NCT ID: NCT06893016

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 640 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2026-09-15

Brief Summary

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

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RAY1225 High Dose

Participants will receive RAY1225 high dose subcutaneously (SC) for 52 weeks.

Group Type: EXPERIMENTAL

RAY1225

Intervention Type: DRUG

RAY1225 will be administered SC

RAY1225 Medium Dose

Participants will receive RAY1225 Medium dose subcutaneously (SC) for 52 weeks.

Group Type: EXPERIMENTAL

RAY1225

Intervention Type: DRUG

RAY1225 will be administered SC

RAY1225 Low Dose

Participants will receive RAY1225 low dose subcutaneously (SC) for 52 weeks.

Group Type: EXPERIMENTAL

RAY1225

Intervention Type: DRUG

RAY1225 will be administered SC

Placebo

Participants will receive placebo SC for 52 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered SC.

Interventions

RAY1225

RAY1225 will be administered SC

Intervention Type: DRUG

Placebo

Placebo will be administered SC.

Intervention Type: DRUG

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Raynovent Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University People's Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ji, Doctor

Role: CONTACT

pkuphiao@163.com

86-10-8831-6815

Facility Contacts

Ji, Doctor

Role: primary

pkuphiao@163.com

86-10-8831-6815

Other Identifiers

RAY1225-24-07

Identifier Type: -

Identifier Source: org_study_id