A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants With Obesity
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijingcun
Contact Information
Primary
JI, professor
iao@pkuph.edu.cn
88326666
Time Frame
Start Date: 2024-02-21
Estimated Completion Date: 2025-12-20
Participants
Target number of participants: 270
Treatments
Experimental: RAY1225 (cohort 1)
Participants received dose1 or dose2 RAY1225 administered subcutaneously (SC) once two week for 24 weeks.
Placebo_comparator: Placebo (cohort 1)
Participants received Placebo administered SC once two weeks for 24 weeks.
Experimental: RAY1225 (cohort 2)
Escalating doses of RAY1225 administered subcutaneously (SC) once two week
Placebo_comparator: Placebo (cohort 2)
Participants received Placebo administered SC once two week
Related Therapeutic Areas
Sponsors
Leads: Guangdong Raynovent Biotech Co., Ltd