Obese But Otherwise Healthy ParticipantsPhase 1CANYON-1NCT07310901

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

A Phase 1 study testing CRB-913 in people with Obese But Otherwise Healthy Participants, run by Corbus Pharmaceuticals Inc. at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Obese But Otherwise Healthy Participants
What is being tested?: CRB-913
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 254 participants
Where: 15 sitesUnited States
Study dates: 4 Dec 2025to 3 Aug 2026
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Part 1: Participants with BMI 18.0-25.0 kg/m²
Part 2: Obese participants with BMI ≥30 kg/m²

Who cannot join

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.

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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

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Central Alabama Research
Birmingham, Alabama, 35209
Neurobehavioral Research
Cedarhurst, New York, 11516
Arizona Clinical Trials
Chandler, Arizona, 85225
Medpace Clinical Pharmacology
Cincinnati, Ohio, 45227
Velocity Clinical Research
Cleveland, Ohio, 44122
Velocity Clinical Research
Dallas, Texas, 75230
Accel Research Sites
DeLand, Florida, 32720
Tampa Bay Medical Research
Largo, Florida, 33761
Alliance Clinical
Las Vegas, Nevada, 89109
Louisville Metabolic and Atherosclerosis Research Center
Louisville, Kentucky, 40213
Quotient Sciences
Miami, Florida, 33126
Lucas Research
Morehead City, North Carolina, 28557
Prospective Research Innovations
Rancho Cucamonga, California, 91730
Rochester Clinical Research
Rochester, New York, 14609
Flourish Research
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A 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

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.

Read the detailed description

CRB-913 is a novel cannabinoid receptor type 1 (CB1) inverse agonist (CB1-IA) that is being developed for once-daily treatment of obesity.

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 will include healthy adult participants. They will receive CRB-913 in tablet form. Researchers will measure how much of the drug enters the bloodstream and how long it stays there.

Part 2 will include participants who will receive one of three different doses of CRB-913 or a placebo (a tablet with no active drug). This part of the study will look at the safety of CRB-913 and its effects on body weight. Researchers will also measure the amount of CRB-913 in the blood.

Part 2 is blinded, which means that participants, study doctors, and the study sponsor will not know who is receiving CRB-913 or placebo.

All participants in Part 2 will take their assigned study tablets for 12 weeks, followed by a 28-day follow-up period after treatment ends.

The information collected in this study will help determine whether CRB-913 is safe, how the body processes it, and whether it may help with weight-related outcomes.

Conditions: Obese But Otherwise Healthy Participants
Being tested: CRB-913, Placebo
Keywords: Obesity, Body Weight, Nutritional and Metabolic Diseases, Metabolic Diseases, Endocrine System Diseases, Overweight, Nutrition Disorders, Cannabinoid-1 receptor inverse agonist
Medical subject headings: Obesity, Body Weight, Nutritional and Metabolic Diseases, Metabolic Diseases, Endocrine System Diseases, Overweight, Nutrition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CRB-913Drug
Administered QD
PlaceboDrug
Administered QD

Study groups in NCT07310901
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Part 1: To evaluate the PK of a single dose of CRB-913 - Cmax
Maximum plasma concentration (Cmax)
Measured: 0 to 48 hours
Part 1: To evaluate the PK of a single dose of CRB-913 - Tmax
Time to maximum plasma concentration (Tmax)
Measured: 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)
Measured: 0 to 48 hours
Part 2: To evaluate the safety of CRB-913 - TEAE
Incidence and severity of treatment emergent adverse events
Measured: 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
Measured: 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
Incidence and severity of treatment emergent adverse events
Measured: Day 1 to 28 days post final dose
Part 2: To evaluate the effect of CRB-913 on weight
Mean change in absolute body weight from baseline to End of Treatment (EOT) compared to placebo
Measured: Day 1 to 28 days post final dose
Part 2: To evaluate the PK of CRB-913 - Cmax
Maximum plasma concentration (Cmax)
Measured: Day 1 to 28 days post final dose
Part 2: To evaluate the PK of CRB-913 - Tmax
Time to maximum plasma concentration (Tmax)
Measured: Day 1 to 28 days post final dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 20253 Aug 2026

First posted30 Dec 2025
Study start4 Dec 2025
Primary completion3 Aug 2026
Study completion3 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Obese But Otherwise Healthy ParticipantsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 254 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07310901
Sponsor's protocol ID: CRB-913-02
Acronym: CANYON-1
Status last verified: Oct 2026
First submitted: 16 Dec 2025
Last updated: 9 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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