Back to search results
NCT07310901

A 2-part, Phase 1b Clinical Study Designed to Evaluate the Safety, PK, and Efficacy of CRB-913 in Participants With Obesity

Active, Not Recruiting
PHASE1Ages 18–75InterventionalTreatment
Corbus Pharmaceuticals Inc.
~252 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:CRB-913Placebo

At a glance

Recruiting sites
0 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: To evaluate the PK of a single dose of CRB-913 - Cmax
Measured over 0 to 48 hours
+4 more outcomes measured

Conditions

Obese But Otherwise Healthy Participants

Explore related trials

ObesityOverweight

Where it's being run

15 sites across 10 states
Florida3
New York2
Ohio2
Texas2
Alabama1
Arizona1
California1
Kentucky1

Study leadership

  • Leela Vrishabhendra, MD · PRINCIPAL_INVESTIGATOR · Medpace Clinical Pharmacology

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Part 1: Participants with BMI 18.0-25.0 kg/m²
Part 2: Obese participants with BMI ≥30 kg/m²

Exclusion

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

What this trial measures

  • Part 1: To evaluate the PK of a single dose of CRB-913 - Cmax0 to 48 hours

    Maximum plasma concentration (Cmax)

  • Part 1: To evaluate the PK of a single dose of CRB-913 - Tmax0 to 48 hours

    Time to maximum plasma concentration (Tmax)

  • Part 1: To evaluate the PK of a single dose of CRB-913 - T1/20 to 48 hours

    Terminal elimination half-life (T1/2)

  • Part 2: To evaluate the safety of CRB-913 - TEAEDay 1 to 28 days post final dose

    Incidence and severity of treatment emergent adverse events

  • Part 2: To evaluate the safety of CRB-913 - AESIDay 1 to 28 days post final dose

    Incidence of adverse events of special interest