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

NCT06893016 | Recruiting Phase 3

• 1 other identifier: RAY1225-24-07
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change From Baseline in Waist Circumference at Week 52

  Baseline and Week 52

Study Arms (4)

RAY1225 High Dose

EXPERIMENTAL

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

Drug: RAY1225

RAY1225 Medium Dose

EXPERIMENTAL

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

Drug: RAY1225

RAY1225 Low Dose

EXPERIMENTAL

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

Drug: RAY1225

Placebo

PLACEBO COMPARATOR

Participants will receive placebo SC for 52 weeks.

Drug: Placebo

Interventions

RAY1225 DRUG

RAY1225 will be administered SC

RAY1225 High Dose; RAY1225 Low Dose; RAY1225 Medium Dose

Placebo DRUG

Placebo will be administered SC.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ji, Doctor

CONTACT

86-10-8831-6815; pkuphiao@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: June 15, 2025
• Primary Completion: June 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-03

Locations

CN (1)