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
Corbus Pharmaceuticals Inc.
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.
Description
CRB-913 is a novel cannabinoid receptor type 1 (CB1) inverse agonist (CB1-IA) that is being developed for once-daily treatment of obesity. This study will look at how the investigational drug CRB-913 behaves in the body and how it affects body weight. The study has two parts: Part 1 will include healthy adult participants. They will receive CRB-913 in tablet form. Researchers will measure how much of the drug enters the bloodstream and how long it stays there. Part 2 will include participants who will receive one of three different doses of CRB-913 or a placebo (a tablet with no active dru…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Part 1: Participants with BMI 18.0-25.0 kg/m² * Part 2: Obese participants with BMI ≥30 kg/m² Exclusion Criteria: * Significant liver disease or moderate-severe hepatic impairment * History of seizures, epilepsy, or intracranial surgery * Diabetes mellitus (Type 1 or Type 2), except gestational * Bariatric surgery or \>5 kg weight change in past 3 months * Recent use (within 3 months) of GLP-1 agonists or other weight-loss medications * Major depression within 2 years. * Any history of suicidal ideation/attempt * Severe psychiatric disorders (e.g., schizophrenia, bipol…
Interventions
- DrugCRB-913
Administered QD
- DrugPlacebo
Administered QD
Locations (15)
- Central Alabama ResearchBirmingham, Alabama
- Arizona Clinical TrialsChandler, Arizona
- Prospective Research InnovationsRancho Cucamonga, California
- Accel Research SitesDeLand, Florida
- Tampa Bay Medical ResearchLargo, Florida
- Quotient SciencesMiami, Florida