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CANYON-1CRB-913 Effects on Body Weight and Safety in Obesity

Study Aim

This phase 1 study aims to evaluate the effects of CRB-913 on body weight and its safety in individuals with obesity.

What is being tested

CRB-913

+ Placebo

Drug

Who is being recruted

Body Weight+7

+ Endocrine System Diseases

+ Metabolic Diseases

From 18 to 75 Years

+22 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 1

Interventional

Study Start: December 2025

See protocol details

Summary

Principal SponsorCorbus Pharmaceuticals Inc.

Study ContactWilliam Moore, BSc. (Hons)More contacts

Last updated: March 19, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 4, 2025

Actual date on which the first participant was enrolled.

This study focuses on an investigational drug called CRB-913, a new type of medication being developed for daily treatment of obesity. The goal is to understand how this drug works in the body and how it impacts body weight. The study involves two groups of participants: healthy adults and individuals with obesity. The research aims to address the challenging issue of obesity, potentially leading to improved care and treatment options for those affected by this condition. In the first part, healthy adults will receive CRB-913 in tablet form. Researchers will track how much of the drug enters the bloodstream and how long it remains there. The second part involves participants with obesity who will receive one of three different doses of CRB-913 or a placebo (a tablet without any active drug). This part will examine the safety of CRB-913 and its effects on body weight, also measuring the amount of CRB-913 in the blood. Participants and researchers will not know who is receiving CRB-913 or the placebo. All participants in the second part will take their assigned tablets for 12 weeks, followed by a 28-day follow-up period after treatment ends.

Official TitleA Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose-Range Finding Study of the Efficacy, Safety, and Pharmacokinetics of CRB-913 in Participants With Obesity With a Single Cohort Open-label Exploratory Pharmacokinetic Lead-In

NCT07310901

Principal SponsorCorbus Pharmaceuticals Inc.

Study ContactWilliam Moore, BSc. (Hons)More contacts

Last updated: March 19, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

252 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightEndocrine System DiseasesMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

2 inclusion criteria required to participate

Part 1: Participants with BMI 18.0-25.0 kg/m^2

Part 2: Obese participants with BMI >= 30 kg/m^2

20 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

5 intervention groups are designated in this study

20% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

Placebo

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.

Group III

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.

Group IV

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.

Group 5

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 15 locations

Recruiting

Central Alabama Research

Birmingham, United StatesOpen Central Alabama Research in Google Maps

Recruiting

Arizona Clinical Trials

Chandler, United States

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Prospective Research Innovations

Rancho Cucamonga, United States

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Accel Research Sites

DeLand, United States

Recruiting

15 Study Centers