A Study of RAY1225 in Participants With Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06254261
• Other study ID #: RAY1225-23-02
• Status: Recruiting
• Phase: Phase 2
• Start date: February 21, 2024
• Est. completion date: February 20, 2025

Study information

• Verified date: February 2024
• Source: Guangdong Raynovent Biotech Co., Ltd
• Contact: JI, professor
• Phone: 88326666
• Email: iao[@]pkuph.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: February 20, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• RAY1225
Administered SC
• Placebo
Placebo

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Raynovent Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Body Weight	Percent Change from Baseline in Body Weight	Baseline,Week26
Secondary	Percentage of Participants Who Achieve =10% Body Weight Reduction		Baseline,Week26
Secondary	Percentage of Participants Who Achieve =15% Body Weight Reduction		Baseline,Week26
Secondary	Percentage of Participants Who Achieve =5% Body Weight Reduction		Baseline,Week26
Secondary	Change from Baseline in Waist Circumference in Centimeter		Baseline,Week26