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

Corbus Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Obese But Otherwise Healthy Participants

Treatments: Drug: CRB-913; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07310901

CRB-913-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 5 patient groups, including a placebo group

Part 1: PK Lead-in

Experimental group

Description:

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.

Treatment:

Drug: CRB-913

Part 2: CRB-913 low dose

Experimental group

Description:

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.

Treatment:

Drug: CRB-913

Part 2: CRB-913 Medium Dose

Experimental group

Description:

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.

Treatment:

Drug: CRB-913

Part 2: CRB-913 High Dose

Experimental group

Description:

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.

Treatment:

Drug: CRB-913

Part 2: Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo