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.
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
- Are there results?
- None posted in the registry
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.
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Corbus Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leela Vrishabhendra, MD, Principal investigator, Medpace Clinical Pharmacology
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07310901
- Acronym / sponsor ID
- CANYON-1 / CRB-913-02
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Corbus Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 3 Aug 2026 (actual)
- Study completion
- 3 Aug 2026 (actual)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1: PK Lead-in | Experimental | Drug: CRB-913Primary 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. |
| Part 2: CRB-913 low dose | Experimental | Drug: CRB-913Primary 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. |
| Part 2: CRB-913 Medium Dose | Experimental | Drug: CRB-913Primary 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. |
| Part 2: CRB-913 High Dose | Experimental | Drug: CRB-913Primary 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. |
| Part 2: Placebo | Placebo comparator | Drug: PlaceboPrimary 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 may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Part 1: Participants with BMI 18.0-25.0 kg/m²
- Part 2: Obese participants with BMI ≥30 kg/m²
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRB-913Administered QD | Drug | Part 1: PK Lead-in, Part 2: CRB-913 High Dose, Part 2: CRB-913 Medium Dose, Part 2: CRB-913 low dose |
| PlaceboAdministered QD | Drug | Part 2: Placebo |
Primary outcome
Part 1: To evaluate the PK of a single dose of CRB-913 - Cmax
Time frame: 0 to 48 hours
Maximum plasma concentration (Cmax)
Part 1: To evaluate the PK of a single dose of CRB-913 - Tmax
Time frame: 0 to 48 hours
Time to maximum plasma concentration (Tmax)
Part 1: To evaluate the PK of a single dose of CRB-913 - T1/2
Time frame: 0 to 48 hours
Terminal elimination half-life (T1/2)
Part 2: To evaluate the safety of CRB-913 - TEAE
Time frame: Day 1 to 28 days post final dose
Incidence and severity of treatment emergent adverse events
Part 2: To evaluate the safety of CRB-913 - AESI
Time frame: Day 1 to 28 days post final dose
Incidence of adverse events of special interest
4 secondary outcomes
Part 1: To evaluate the safety of a single dose of CRB-913 - TEAE
Time frame: Day 1 to 28 days post final dose
Part 2: To evaluate the effect of CRB-913 on weight
Time frame: Day 1 to 28 days post final dose
Part 2: To evaluate the PK of CRB-913 - Cmax
Time frame: Day 1 to 28 days post final dose
Part 2: To evaluate the PK of CRB-913 - Tmax
Time frame: Day 1 to 28 days post final dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leela Vrishabhendra, MD principal investigator
Medpace Clinical Pharmacology
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: To evaluate the PK of a single dose of CRB-913 - Cmax (time frame: 0 to 48 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.