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

NCT07310901 · tracked via the Priya Life Science USA tracker

Sponsor

Corbus Pharmaceuticals Inc.

Phase

Phase 1

Started

2025-12-04

Last updated

2026-05-29

Condition(s) studied

Obese But Otherwise Healthy Participants

Investigational drug(s) / intervention(s)

CRB-913Placebo

CRB-913: Administered QD

Placebo: Administered QD

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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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

Primary outcome measure(s)

Part 1: To evaluate the PK of a single dose of CRB-913 - Cmax — 0 to 48 hours
Maximum plasma concentration (Cmax)
Part 1: To evaluate the PK of a single dose of CRB-913 - Tmax — 0 to 48 hours
Time to maximum plasma concentration (Tmax)
Part 1: To evaluate the PK of a single dose of CRB-913 - T1/2 — 0 to 48 hours
Terminal elimination half-life (T1/2)
Part 2: To evaluate the safety of CRB-913 - TEAE — Day 1 to 28 days post final dose
Incidence and severity of treatment emergent adverse events
Part 2: To evaluate the safety of CRB-913 - AESI — Day 1 to 28 days post final dose
Incidence of adverse events of special interest

Trial sites (15)

Facility	City	Region
Central Alabama Research	Birmingham	Alabama
Arizona Clinical Trials	Chandler	Arizona
Prospective Research Innovations	Rancho Cucamonga	California
Accel Research Sites	DeLand	Florida
Tampa Bay Medical Research	Largo	Florida
Quotient Sciences	Miami	Florida
Louisville Metabolic and Atherosclerosis Research Center	Louisville	Kentucky
Alliance Clinical	Las Vegas	Nevada
Neurobehavioral Research	Cedarhurst	New York
Rochester Clinical Research	Rochester	New York
Lucas Research	Morehead City	North Carolina
Medpace Clinical Pharmacology	Cincinnati	Ohio
Velocity Clinical Research	Cleveland	Ohio
Velocity Clinical Research	Dallas	Texas
Flourish Research	San Antonio	Texas

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07310901 on ClinicalTrials.gov ↗ ← All trials in the USA