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

Last updated: May 27, 2026
Sponsor: Corbus Pharmaceuticals Inc.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Obesity

Diabetes Prevention

Metabolic Disorders

Treatment

Placebo

CRB-913

Clinical Study ID

NCT07310901
CRB-913-02
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Part 1: Participants with BMI 18.0-25.0 kg/m²

  • Part 2: Obese participants with BMI ≥30 kg/m²

Exclusion

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 resectednonmelanoma 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 ornon-feasible

Study Design

Total Participants: 252
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
December 04, 2025
Estimated Completion Date:
July 31, 2026

Study 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 drug). This part of the study will look at the safety of CRB-913 and its effects on body weight. Researchers will also measure the amount of CRB-913 in the blood.

Part 2 is blinded, which means that participants, study doctors, and the study sponsor will not know who is receiving CRB-913 or placebo.

All participants in Part 2 will take their assigned study tablets for 12 weeks, followed by a 28-day follow-up period after treatment ends.

The information collected in this study will help determine whether CRB-913 is safe, how the body processes it, and whether it may help with weight-related outcomes.

Connect with a study center

  • Central Alabama Research

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Arizona Clinical Trials

    Chandler, Arizona 85225
    United States

    Site Not Available

  • Prospective Research Innovations

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • Accel Research Sites

    DeLand, Florida 32720
    United States

    Site Not Available

  • Tampa Bay Medical Research

    Largo, Florida 33761
    United States

    Site Not Available

  • Quotient Sciences

    Miami, Florida 33126
    United States

    Site Not Available

  • Louisville Metabolic and Atherosclerosis Research Center

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Alliance Clinical

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Neurobehavioral Research

    Cedarhurst, New York 11516
    United States

    Site Not Available

  • Rochester Clinical Research

    Rochester, New York 14609
    United States

    Site Not Available

  • Lucas Research

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Medpace Clinical Pharmacology

    Cincinnati, Ohio 45227
    United States

    Site Not Available

  • Velocity Clinical Research

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Velocity Clinical Research

    Dallas, Texas 75230
    United States

    Site Not Available

  • Flourish Research

    San Antonio, Texas 78229
    United States

    Site Not Available

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