CRB-913: a once-daily pill being tested for weight loss in adults with obesity
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
This study will test whether a once-daily pill called CRB-913 is safe and helps adults with obesity lose weight.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Corbus Pharmaceuticals Inc. Industry-sponsored |
| Locations | 15 sites (Birmingham, Alabama and 14 other locations) |
| Trial ID | NCT07310901 on ClinicalTrials.gov |
What this trial studies
CRB-913 is a novel cannabinoid receptor type 1 (CB1) inverse agonist being developed as a once-daily treatment for obesity. This Phase 1b study has two parts: Part 1 will give CRB-913 tablets to healthy adults (BMI 18–25) to measure how the drug is absorbed and cleared. Part 2 will randomize adults with obesity (BMI ≥30) to one of three doses or placebo for 12 weeks in a blinded comparison to measure safety, changes in body weight, and blood drug levels, with a 28-day follow-up. The trial excludes people with diabetes, recent weight-loss surgery, significant liver disease, or certain psychiatric conditions to reduce safety risks.
Who should consider this trial
Good fit: Adults with obesity (BMI ≥30 kg/m²) without diabetes, significant liver disease, or major psychiatric disorders who meet other study criteria are the intended participants.
Not a fit: People with diabetes, significant hepatic impairment, recent bariatric surgery, recent use of certain weight-loss drugs, or a history of major depression or suicidal ideation are unlikely to be eligible or to benefit from this study.
Why it matters
Potential benefit: If successful, CRB-913 could offer a once-daily medication that helps adults with obesity lose weight.
How similar studies have performed: Other CB1-targeting drugs have produced weight loss in past trials but were associated with psychiatric side effects, so this approach has precedent but requires careful safety monitoring.
Eligibility criteria
Show full inclusion / exclusion criteria
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, bipolar disorder) * Elevated screening scores: PHQ-9 \>4, GAD-7 \>4, or positive C-SSRS Items 1-2 * Active or recent (within 5 years) malignancy (exceptions: in situ and fully resected nonmelanoma skin cancer) * Abnormal thyroid function: TSH \>6 mIU/L unless stable on replacement therapy * QTc \>470 msec (females) or \>450 msec (males) or history of long QT syndrome * Use of systemic corticosteroids or unstable chronic medications affecting BP, lipids, or glucose * Use of CYP3A4 substrates or strong P-gp substrates/inhibitors * Investigational drug use within 28 days * Prior exposure to CRB-913 or other CB1 inverse agonists/antagonists * Substance abuse history * Pregnancy, breastfeeding, or unwillingness to use highly effective contraception * Positive drug or alcohol screen * Any condition that, in the investigator's judgment, makes participation unsafe or non-feasible
Where this trial is running
Birmingham, Alabama and 14 other locations
- Central Alabama Research — Birmingham, Alabama, United States (Recruiting)
- Arizona Clinical Trials — Chandler, Arizona, United States (Recruiting)
- Prospective Research Innovations — Rancho Cucamonga, California, United States (Recruiting)
- Accel Research Sites — DeLand, Florida, United States (Recruiting)
- Tampa Bay Medical Research — Largo, Florida, United States (Recruiting)
- Quotient Sciences — Miami, Florida, United States (Recruiting)
- Louisville Metabolic and Atherosclerosis Research Center — Louisville, Kentucky, United States (Recruiting)
- Alliance Clinical — Las Vegas, Nevada, United States (Recruiting)
- Neurobehavioral Research — Cedarhurst, New York, United States (Recruiting)
- Rochester Clinical Research — Rochester, New York, United States (Recruiting)
- Lucas Research — Morehead City, North Carolina, United States (Recruiting)
- Medpace Clinical Pharmacology — Cincinnati, Ohio, United States (Recruiting)
- Velocity Clinical Research — Cleveland, Ohio, United States (Recruiting)
- Velocity Clinical Research — Dallas, Texas, United States (Recruiting)
- Flourish Research — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Leela Vrishabhendra, MD — Medpace Clinical Pharmacology
- Study coordinator: William Moore, BSc. (Hons)
- Email: clinical@corbuspharma.com
- Phone: +1 617 963 0100
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.