A Study of RAY1225 in Participants With Obesity

Launched by GUANGDONG RAYNOVENT BIOTECH CO., LTD · Feb 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called RAY1225 for people with obesity. The main goal is to see how well this treatment is tolerated and whether it helps with weight loss. The study will involve participants for about six months, during which they will receive the treatment and be monitored for any effects.

To be eligible for this study, participants should have a body mass index (BMI) of 28 or higher, or a BMI of 24 or higher along with certain weight-related health issues like high blood pressure or sleep apnea. It's important that participants use reliable birth control during the study and for six months after their last treatment. Those with specific health conditions, like certain types of thyroid problems or a history of diabetes, will not be able to participate. If you join, you can expect regular check-ins with the research team to monitor your health and how you’re responding to the treatment.

Gender

ALL

Eligibility criteria

• 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.