A Study of RAY1225 in Participants With Obesity

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants With Obesity

The main purpose of this study is to learn more about the Tolerability of RAY1225 in participants with Obesity. The study will also explore the efficacy of RAY1225. The study will last about six months for each participant.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: Placebo; Drug: RAY1225

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: JI, professor; Phone Number: 88326666; Email: iao@pkuph.edu.cn

Study Locations

• China
  • Hebei
    • Beijing, Hebei, China
      • Recruiting
      • Peking University People's Hospital
      • Contact: JI, professor; Phone Number: 88326666; Email: iao@pkuph.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Have a body mass index (BMI) of ≥28 kilogram per square meter (kg/m²) or ≥24 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, fatty liver disease,or HbA1c ≥5.7% and < 6.5%;
2. Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.

Exclusion Criteria:

1. Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
2. with a history of diabetes or hypoglycemia;
3. Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2 or with thyroid nodules of unknown etiology found at screening and considered clinically significant by the investigator.
4. Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)
5. allergic constitution;
6. not suitable for subcutaneous injection.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RAY1225 (cohort 1); Participants received dose1 or dose2 RAY1225 administered subcutaneously (SC) once two week for 24 weeks.	Drug: RAY1225; Administered SC
Placebo Comparator: Placebo (cohort 1); Participants received Placebo administered SC once two weeks for 24 weeks.	Drug: Placebo; Placebo
Experimental: RAY1225 (cohort 2); Escalating doses of RAY1225 administered subcutaneously (SC) once two week	Drug: RAY1225; Administered SC
Placebo Comparator: Placebo (cohort 2); Participants received Placebo administered SC once two week	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Body Weight	Percent Change from Baseline in Body Weight	Baseline,Week26

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Who Achieve ≥10% Body Weight Reduction	Baseline,Week26
Percentage of Participants Who Achieve ≥15% Body Weight Reduction	Baseline,Week26
Percentage of Participants Who Achieve ≥5% Body Weight Reduction	Baseline,Week26
Change from Baseline in Waist Circumference in Centimeter	Baseline,Week26

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Estimated): December 20, 2025
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: February 3, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: RAY1225-23-02

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