A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose-Range Finding Study of the Efficacy, Safety, and Pharmacokinetics of CRB-913 in Participants With Obesity With a Single Cohort Open-label Exploratory Pharmacokinetic Lead-In
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This study will assess the safety of the investigational drug CRB-913 and how it is processed in the body. The study has two parts: Part 1 will measure drug levels in healthy adults after taking CRB-913 tablets, and Part 2 will compare three doses of CRB-913 with placebo to evaluate safety, effects on body weight, and drug levels in the blood. Part 2 is blinded, meaning participants, study doctors, and the sponsor will not know which treatment is given. Participants in Part 2 will take study treatment for 12 weeks and will be followed for 28 days after treatment ends.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Part 1: Participants with BMI 18.0-25.0 kg/m²
• Part 2: Obese participants with BMI ≥30 kg/m²
Locations
United States
Alabama
Central Alabama Research
RECRUITING
Birmingham
Arizona
Arizona Clinical Trials
NOT_YET_RECRUITING
Chandler
California
Prospective Research Innovations
NOT_YET_RECRUITING
Rancho Cucamonga
Florida
Accel Research Sites
NOT_YET_RECRUITING
Deland
Tampa Bay Medical Research
NOT_YET_RECRUITING
Largo
Quotient Sciences
NOT_YET_RECRUITING
Miami
Kentucky
Louisville Metabolic and Atherosclerosis Research Center
NOT_YET_RECRUITING
Louisville
North Carolina
Lucas Research
NOT_YET_RECRUITING
Morehead City
Nevada
Alliance Clinical
NOT_YET_RECRUITING
Las Vegas
New York
Neurobehavioral Research
NOT_YET_RECRUITING
Cedarhurst
Rochester Clinical Research
NOT_YET_RECRUITING
Rochester
Ohio
Medpace Clinical Pharmacology
RECRUITING
Cincinnati
Velocity Clinical Research
NOT_YET_RECRUITING
Cleveland
Texas
Velocity Clinical Research
NOT_YET_RECRUITING
Dallas
Flourish Research
NOT_YET_RECRUITING
San Antonio
Contact Information
Primary
William Moore, BSc. (Hons)
clinical@corbuspharma.com
+1 617 963 0100
Backup
Ian Hodgson, PhD
clinical@corbuspharma.com
+1 617 963 0100
Time Frame
Start Date: 2025-12-04
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 252
Treatments
Experimental: Part 1: PK Lead-in
Primary Treatment Period (Day 1): Participants will receive a single dose of CRB-913. Following Part 1 of the study Part 2 will open for recruitment.~Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period.
Experimental: Part 2: CRB-913 low dose
Primary Treatment Period (Day 0-Day 85): Participants will receive CRB-913 low dose which is maintained up to day 85.~Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period.
Experimental: Part 2: CRB-913 Medium Dose
Primary Treatment Period (Day 0-Day 85): Participants will receive CRB-913 starting at low dose for 14 days and increasing to medium dose at day 15 which is maintained up to day 85.~Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period.
Experimental: Part 2: CRB-913 High Dose
Primary Treatment Period (Day 0 - Day 85): Participants will receive CRB-913 starting at low dose for 14 days, increasing to medium dose at day 15 for 14 days and then increased to high dose at day 29 which is maintained up to day 85.~Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period.
Placebo_comparator: Part 2: Placebo
Primary Treatment Period (Day 0-Day 85): Participants will receive CRB-913 matching placebo which is maintained up to day 85.~Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period.
Related Therapeutic Areas
Sponsors
Leads: Corbus Pharmaceuticals Inc.