CRB-913 for Obesity
(CANYON-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an investigational drug, CRB-913, to evaluate its safety and effects on the body, with a specific focus on body weight. In Part 1, the study examines how healthy adults process the drug. Part 2 compares different doses of CRB-913 with a placebo to determine which is safest and most effective. Individuals with obesity and a BMI (body mass index) of 30 or higher may qualify for Part 2. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Will I have to stop taking my current medications?
The trial does not specify if you must stop all current medications, but you cannot use certain drugs like weight-loss medications, systemic corticosteroids, or specific substances that affect blood pressure, lipids, or glucose. Check with the study team about your specific medications.
Is there any evidence suggesting that CRB-913 is likely to be safe for humans?
Research has shown that CRB-913 was safe and well-tolerated in earlier studies. Participants in these studies experienced no serious side effects, regardless of the dose. Daily checks for mood and anxiety revealed no issues. These findings suggest that CRB-913 is likely safe for people, but further research will help confirm this.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about CRB-913 for obesity because it offers a potentially new approach to weight management compared to traditional treatments like lifestyle changes or medications such as orlistat and phentermine. Unlike these options, which often focus on reducing fat absorption or suppressing appetite, CRB-913 might work by targeting specific pathways in the body that regulate metabolism more directly. This novel mechanism could not only lead to more effective weight loss but also potentially offer improved safety and fewer side effects. The different dosing options being tested—low, medium, and high—allow for flexibility in finding the most effective and safe dosage for various people.
What evidence suggests that CRB-913 might be an effective treatment for obesity?
Research has shown that CRB-913, the investigational treatment in this trial, may aid in weight loss. In one study, participants taking CRB-913 lost an average of 2.9% of their body weight by Day 14, compared to those on a placebo. Individual weight loss ranged from 1.3% and higher. CRB-913 blocks certain brain signals that can lead to weight gain. The study also found it to be safe and well-tolerated at various doses. These findings suggest CRB-913 could be useful for treating obesity, but further research is needed to confirm these results.12367
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Part 1: PK Lead-in
Participants receive a single dose of CRB-913 to evaluate pharmacokinetics
Part 1: Safety Follow-up
Participants are followed for safety for 28 days after the single dose
Part 2: Treatment
Participants receive CRB-913 or placebo for 12 weeks to evaluate safety and efficacy
Part 2: Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
5
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Corbus Pharmaceuticals Inc.
Lead Sponsor
Citations
Corbus Pharmaceuticals Reports Results from Phase 1a ...
The CRB-913-treated participants achieved a mean 2.9% placebo-adjusted weight loss by Day 14. Individual participant weight loss ranged from 1.3 ...
A 2-part, Phase 1b Clinical Study Designed to Evaluate the ...
A 2-part, Phase 1b Clinical Study Designed to Evaluate the Safety, PK, and Efficacy of CRB-913 in Participants With Obesity (CANYON-1).
3.
finance.yahoo.com
finance.yahoo.com/news/corbus-pharmaceuticals-reports-results-phase-120000223.htmlCorbus Pharmaceuticals Reports Results from Phase 1a ...
CRB-913 was safe and well-tolerated across all doses studied. Daily neuropsychiatric assessments using CSSRS, PHQ-9, and GAD-7 were negative ...
Novel cannabinoid receptor 1 inverse agonist CRB‐913 ...
In further DIO studies in combination with tirzepatide, semaglutide, or liraglutide, CRB-913 (2.5 mg/kg) resulted in −32.6%, −28.8%, and −16.8% ...
A 2-part, Phase 1b Clinical Study Designed to Evaluate the ...
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 ...
CRB-913 Inverse Agonist Biology Obesity Treatment
CRB-913 has generated pre-clinical data indicating its potential as a standalone treatment (monotherapy), maintenance therapy, and in combination with incretin ...
7.
clinicaltrialvanguard.com
clinicaltrialvanguard.com/news/corbus-pharmaceuticals-initiates-phase-1-study-of-crb-913-for-obesity-treatment/Corbus Pharmaceuticals Initiates Phase 1 Study of CRB- ...
The successful progression of CRB-913 to the MAD stage represents a crucial step toward validating its potential as a safer obesity treatment.
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