CRB-913 for Obesity

(CANYON-1 Trial)

Recruiting at 14 trial locations

Overseen By Ian Hodgson, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Corbus Pharmaceuticals Inc.

Must not be taking: GLP-1 agonists, Corticosteroids, CYP3A4 substrates, others

Disqualifiers: Liver disease, Seizures, Diabetes, Depression, others

Compensation: Varies

Number of Visits: 1

252 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Leela Vrishabhendra, MD

Principal Investigator

Medpace Clinical Pharmacology

Are You a Good Fit for This Trial?

This trial is for adults with obesity, including related conditions like metabolic disorders. Participants must be healthy enough to take the drug CRB-913 and follow the study procedures. Specific details on who can or cannot participate are not provided here.

Inclusion Criteria

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

My BMI is 30 or higher.

Exclusion Criteria

QTc >470 msec (females) or >450 msec (males) or history of long QT syndrome

Investigational drug use within 28 days

Substance abuse history

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1: PK Lead-in

Participants receive a single dose of CRB-913 to evaluate pharmacokinetics

0 to 48 hours

1 visit (in-person)

Part 1: Safety Follow-up

Participants are followed for safety for 28 days after the single dose

4 weeks

Part 2: Treatment

Participants receive CRB-913 or placebo for 12 weeks to evaluate safety and efficacy

12 weeks

Part 2: Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CRB-913

Trial Overview

The trial is testing CRB-913's safety and how it's processed in the body compared to a placebo. It has two parts: one measures drug levels after intake, and another tests three doses' effects on weight over 12 weeks, followed by a 28-day observation.

How Is the Trial Designed?

Group I: Part 2: CRB-913 low dose Experimental Treatment 1 Intervention

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.

Group II: Part 2: CRB-913 Medium Dose Experimental Treatment 1 Intervention

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.

Group III: Part 2: CRB-913 High Dose Experimental Treatment 1 Intervention

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.

Group IV: Part 1: PK Lead-in Experimental Treatment 1 Intervention

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.

Group V: Part 2: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Corbus Pharmaceuticals Inc.

Lead Sponsor

Trials

9

Recruited

1,800+