RecruitingPhase 2NCT06254261

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

Sponsor

Guangdong Raynovent Biotech Co., Ltd

Enrollment

270 participants

Start Date

Feb 21, 2024

Study Type

INTERVENTIONAL

Conditions

Obesity

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria2

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%;
Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.

Exclusion Criteria6

Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
with a history of diabetes or hypoglycemia;
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.
Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)
allergic constitution;
not suitable for subcutaneous injection.

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