Evaluating RAY1225 for treating obesity
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants With Obesity
This study is testing a new treatment called RAY1225 to see if it can help people with obesity lose weight and improve their health over six months.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Guangdong Raynovent Biotech Co., Ltd Industry-sponsored |
| Locations | 1 site (Beijingcun, Hebei) |
| Trial ID | NCT06254261 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the tolerability and efficacy of RAY1225 in individuals with obesity. Participants will receive either RAY1225 or a placebo over a six-month period. The study will focus on understanding how well the treatment is tolerated and its effectiveness in reducing obesity-related health issues. Inclusion criteria require participants to have a BMI of 28 or higher, or 24 with specific weight-related comorbidities.
Who should consider this trial
Good fit: Ideal candidates are adults with a BMI of 28 or higher, or 24 with certain obesity-related conditions.
Not a fit: Patients with obesity due to endocrinologic disorders or those with a history of diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for managing obesity and its associated health risks.
How similar studies have performed: Other studies exploring similar pharmacological approaches to obesity have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijingcun, Hebei
- Peking University People's Hospital — Beijingcun, Hebei, China (Recruiting)
Study contacts
- Study coordinator: JI, professor
- Email: iao@pkuph.edu.cn
- Phone: 88326666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.