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A Study to Evaluate the Efficacy and Safety of CX11 Tablets in Overweight/Obese Participants
Sponsor: Corxel Pharmaceuticals
Summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study: * To evaluate the efficacy of different dose levels of CX11 tablets in body weight reduction as compared to placebo. * To compare the changes of effects in weight and weight-related indicators at the visit time points. * To evaluate the tolerability and safety of different doses of CX11 tablets in overweight/obese participants. * To assess the pharmacokinetics (PK) of different doses of CX11 tablets in overweight/obese participants. Overweight/obese participants who are successfully screened will be randomized in a 1:1:1:1:1 ratio to different doses of CX11 tablets or placebo. All participants will enter a 2-week follow-up period after 36 weeks of treatment for safety observation.
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of CX11 Tablets in Overweight/Obese Participants
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2025-06-17
Completion Date
2026-04-06
Last Updated
2025-08-14
Healthy Volunteers
No
Conditions
Interventions
CX11
CX11 tablets administered orally once daily (QD) with meals
Placebo
Matching placebo tablets administered orally once daily (QD) with meals
Locations (17)
AES - DRS - Synexus Clinical Research US, Inc. - Phoenix Central
Phoenix, Arizona, United States
310 Clinical Research - Alliance Clinical - Los Angeles
Inglewood, California, United States
Acclaim Clinical Research - Alliance Clinical - San Diego
San Diego, California, United States
Angels Clinical Research Institute - Miami
Doral, Florida, United States
AES - DRS - Optimal Research Florida - Melbourne
Melbourne, Florida, United States
Angels Clinical Research Institute
Miami, Florida, United States
Palm Springs Community Health Center
Miami Lakes, Florida, United States
Oceanic Research Group, LLC
North Miami Beach, Florida, United States
Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS
Savannah, Georgia, United States
Privia Medical Group Georgia, LLC - Thomasville - Javara - PPDS
Thomasville, Georgia, United States
Velocity Clinical Research - Valparaiso (Buynak Clinical Research) - PPDS
Valparaiso, Indiana, United States
Mankato Clinic - East Main Street - Javara - PPDS
Mankato, Minnesota, United States
Velocity Clinical Research - Cincinnati (Springdale) - Ohio - PPDS
Cincinnati, Ohio, United States
Velocity Clinical Research - Dallas - PPDS
Dallas, Texas, United States
Epic Clinical Research - Alliance Clinical - Lewisville
Lewisville, Texas, United States
AES - DRS - Synexus Clinical Research US, Inc. - San Antonio
San Antonio, Texas, United States
Flourish Research - San Antonio - PPDS
San Antonio, Texas, United States