A Study of RAY1225 in Participants With Obesity

Phase 2

Recruiting

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

• Registration Number: NCT06254261
• Lead Sponsor: Guangdong Raynovent Biotech Co., Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-03
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-12
• Study Start: 2024-02-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-12-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (cohort 1)	Placebo	Participants received Placebo administered SC once two weeks for 24 weeks.
RAY1225 (cohort 2)	RAY1225	Escalating doses of RAY1225 administered subcutaneously (SC) once two week
Placebo (cohort 2)	Placebo	Participants received Placebo administered SC once two week
RAY1225 (cohort 1)	RAY1225	Participants received dose1 or dose2 RAY1225 administered subcutaneously (SC) once two week for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Body Weight	Baseline,Week26	Percent Change from Baseline in Body Weight

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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