Actively Recruiting
A 2-part, Phase 1b Clinical Study Designed to Evaluate the Safety, PK, and Efficacy of CRB-913 in Participants With Obesity
Led by Corbus Pharmaceuticals Inc. · Updated on 2026-03-18
252
Participants Needed
15
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
A 2-part, Phase 1b Clinical Study Designed to Evaluate the Safety, PK, and Efficacy of CRB-913 in Participants With Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Part 1: Participants with BMI 18.0-25.0 kg/m8
- Part 2: Obese participants with BMI 630 kg/m8
- Age between 18 and 75 years
You will not qualify if you...
- Significant liver disease or moderate-severe hepatic impairment
- History of seizures, epilepsy, or intracranial surgery
- Diabetes mellitus (Type 1 or Type 2), except gestational diabetes
- Bariatric surgery or more than 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 or attempt
- Severe psychiatric disorders such as schizophrenia or 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 except certain skin cancers
- Abnormal thyroid function (TSH >6 mIU/L) unless stable on therapy
- QTc >470 msec (females) or >450 msec (males) or history of long QT syndrome
- Use of systemic corticosteroids or unstable chronic medications affecting blood pressure, 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
- History of substance abuse
- Pregnancy, breastfeeding, or unwillingness to use effective contraception
- Positive drug or alcohol screen
- Any condition making participation unsafe or not feasible as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 15 locations
1
Central Alabama Research
Birmingham, Alabama, United States, 35209
Actively Recruiting
2
Arizona Clinical Trials
Chandler, Arizona, United States, 85225
Actively Recruiting
3
Prospective Research Innovations
Rancho Cucamonga, California, United States, 91730
Actively Recruiting
4
Accel Research Sites
DeLand, Florida, United States, 32720
Actively Recruiting
5
Tampa Bay Medical Research
Largo, Florida, United States, 33761
Actively Recruiting
6
Quotient Sciences
Miami, Florida, United States, 33126
Actively Recruiting
7
Louisville Metabolic and Atherosclerosis Research Center
Louisville, Kentucky, United States, 40213
Actively Recruiting
8
Alliance Clinical
Las Vegas, Nevada, United States, 89109
Actively Recruiting
9
Neurobehavioral Research
Cedarhurst, New York, United States, 11516
Actively Recruiting
10
Rochester Clinical Research
Rochester, New York, United States, 14609
Actively Recruiting
11
Lucas Research
Morehead City, North Carolina, United States, 28557
Actively Recruiting
12
Medpace Clinical Pharmacology
Cincinnati, Ohio, United States, 45227
Actively Recruiting
13
Velocity Clinical Research
Cleveland, Ohio, United States, 44122
Actively Recruiting
14
Velocity Clinical Research
Dallas, Texas, United States, 75230
Actively Recruiting
15
Flourish Research
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
W
William Moore, BSc. (Hons)
CONTACT
I
Ian Hodgson, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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