A 2-part, Phase 1b Clinical Study Designed to Evaluate the Safety, PK, and Efficacy of CRB-913 in Participants 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
Corbus Pharmaceuticals Inc.
252 participants
Dec 4, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- Part 1: Participants with BMI 18.0-25.0 kg/m²
- Part 2: Obese participants with BMI ≥30 kg/m²
Exclusion Criteria20
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Administered QD
Administered QD
Locations(15)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07310901