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

NCT07310901 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CRB-913-02
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Obese But Otherwise Healthy Participants

Keywords

Obesity; Body Weight; Nutritional and Metabolic Diseases; Metabolic Diseases; Endocrine System Diseases; Overweight; Nutrition Disorders; Cannabinoid-1 receptor inverse agonist

Outcome Measures

Primary Outcomes (5)

• Part 1: To evaluate the PK of a single dose of CRB-913 - Cmax

  Maximum plasma concentration (Cmax)

  0 to 48 hours

• Part 1: To evaluate the PK of a single dose of CRB-913 - Tmax

  Time to maximum plasma concentration (Tmax)

  0 to 48 hours

• Part 1: To evaluate the PK of a single dose of CRB-913 - T1/2

  Terminal elimination half-life (T1/2)

  0 to 48 hours

• Part 2: To evaluate the safety of CRB-913 - TEAE

  Incidence and severity of treatment emergent adverse events

  Day 1 to 28 days post final dose

• Part 2: To evaluate the safety of CRB-913 - AESI

  Incidence of adverse events of special interest

  Day 1 to 28 days post final dose

Secondary Outcomes (4)

• Part 1: To evaluate the safety of a single dose of CRB-913 - TEAE

  Day 1 to 28 days post final dose

• Part 2: To evaluate the effect of CRB-913 on weight

  Day 1 to 28 days post final dose

• Part 2: To evaluate the PK of CRB-913 - Cmax

  Day 1 to 28 days post final dose

• Part 2: To evaluate the PK of CRB-913 - Tmax

  Day 1 to 28 days post final dose

Other Outcomes (1)

• Part 2: To evaluate changes in food noise

  Day 1 to 28 days post final dose

Study Arms (5)

Part 1: PK Lead-in

EXPERIMENTAL

Primary Treatment Period (Day 1): Participants will receive a single dose of CRB-913. Following Part 1 of the study Part 2 will open for recruitment. Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period.

Drug: CRB-913

Part 2: CRB-913 low dose

EXPERIMENTAL

Primary Treatment Period (Day 0-Day 85): Participants will receive CRB-913 low dose which is maintained up to day 85. Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period.

Drug: CRB-913

Part 2: CRB-913 Medium Dose

EXPERIMENTAL

Primary Treatment Period (Day 0-Day 85): Participants will receive CRB-913 starting at low dose for 14 days and increasing to medium dose at day 15 which is maintained up to day 85. Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period.

Drug: CRB-913

Part 2: CRB-913 High Dose

EXPERIMENTAL

Primary Treatment Period (Day 0 - Day 85): Participants will receive CRB-913 starting at low dose for 14 days, increasing to medium dose at day 15 for 14 days and then increased to high dose at day 29 which is maintained up to day 85. Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period.

Drug: CRB-913

Part 2: Placebo

PLACEBO COMPARATOR

Primary Treatment Period (Day 0-Day 85): Participants will receive CRB-913 matching placebo which is maintained up to day 85. Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period.

Drug: Placebo

Interventions

CRB-913 DRUG

Administered QD

Part 1: PK Lead-in; Part 2: CRB-913 High Dose; Part 2: CRB-913 Medium Dose; Part 2: CRB-913 low dose

Placebo DRUG

Administered QD

Part 2: Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Corbus Pharmaceuticals Inc.: lead

Study Sites (15)

Central Alabama Research

Birmingham, Alabama, 35209, United States

RECRUITING

Arizona Clinical Trials

Chandler, Arizona, 85225, United States

RECRUITING

Prospective Research Innovations

Rancho Cucamonga, California, 91730, United States

RECRUITING

Accel Research Sites

DeLand, Florida, 32720, United States

RECRUITING

Tampa Bay Medical Research

Largo, Florida, 33761, United States

RECRUITING

Quotient Sciences

Miami, Florida, 33126, United States

RECRUITING

Louisville Metabolic and Atherosclerosis Research Center

Louisville, Kentucky, 40213, United States

RECRUITING

Alliance Clinical

Las Vegas, Nevada, 89109, United States

RECRUITING

Neurobehavioral Research

Cedarhurst, New York, 11516, United States

RECRUITING

Rochester Clinical Research

Rochester, New York, 14609, United States

RECRUITING

Lucas Research

Morehead City, North Carolina, 28557, United States

RECRUITING

Medpace Clinical Pharmacology

Cincinnati, Ohio, 45227, United States

RECRUITING

Velocity Clinical Research

Cleveland, Ohio, 44122, United States

RECRUITING

Velocity Clinical Research

Dallas, Texas, 75230, United States

RECRUITING

Flourish Research

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Body Weight; Nutritional and Metabolic Diseases; Metabolic Diseases; Endocrine System Diseases; Overweight; Nutrition Disorders

Condition Hierarchy (Ancestors)

Overnutrition; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Leela Vrishabhendra, MD

  Medpace Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Moore, BSc. (Hons)

CONTACT

+1 617 963 0100; clinical@corbuspharma.com

Ian Hodgson, PhD

CONTACT

+1 617 963 0100; clinical@corbuspharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Part 1 is open label. Part 2 is double blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): July 2, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (15)