A 2-part, Phase 1b Clinical Study Designed to Evaluate the Safety, PK, and Efficacy of CRB-913 in Participants With Obesity
Running, not enrolling · Phase 1 · Has a placebo group
Conditions studied: Obese But Otherwise Healthy Participants
In brief
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.
Key facts
- Study ID
- NCT07310901
- Run by
- Corbus Pharmaceuticals Inc.
- People needed
- 252
- Starts
- 2025-12-04
- Expected to finish
- 2026-07-31
- Last updated by the study team
- 2026-05-29
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Part 1: Participants with BMI 18.0-25.0 kg/m²
- Part 2: Obese participants with BMI ≥30 kg/m²
You may not qualify if…
- 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 it is running
- Central Alabama Research — Birmingham, Alabama, United States
- Arizona Clinical Trials — Chandler, Arizona, United States
- Prospective Research Innovations — Rancho Cucamonga, California, United States
- Accel Research Sites — DeLand, Florida, United States
- Tampa Bay Medical Research — Largo, Florida, United States
- Quotient Sciences — Miami, Florida, United States
- Louisville Metabolic and Atherosclerosis Research Center — Louisville, Kentucky, United States
- Alliance Clinical — Las Vegas, Nevada, United States
- Neurobehavioral Research — Cedarhurst, New York, United States
- Rochester Clinical Research — Rochester, New York, United States
- Lucas Research — Morehead City, North Carolina, United States
- Medpace Clinical Pharmacology — Cincinnati, Ohio, United States
- Velocity Clinical Research — Cleveland, Ohio, United States
- Velocity Clinical Research — Dallas, Texas, United States
- Flourish Research — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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