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

July 15, 2025 updated by: Guangdong Raynovent Biotech Co., Ltd

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants Who Have Obesity or Are Overweight

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

640

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RAY1225 High Dose
Participants will receive RAY1225 high dose subcutaneously (SC) for 52 weeks.
Drug: RAY1225
RAY1225 will be administered SC
Experimental: RAY1225 Medium Dose
Participants will receive RAY1225 Medium dose subcutaneously (SC) for 52 weeks.
Drug: RAY1225
RAY1225 will be administered SC
Experimental: RAY1225 Low Dose
Participants will receive RAY1225 low dose subcutaneously (SC) for 52 weeks.
Drug: RAY1225
RAY1225 will be administered SC
Placebo Comparator: Placebo
Participants will receive placebo SC for 52 weeks.
Drug: Placebo
Placebo will be administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in Body Weight at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Number of Participants who Achieved a ≥ 5% Reduction in Body Weight from Baseline at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Waist Circumference at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Raynovent Biotech Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2025

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAY1225-24-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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