A Phase 1 interventional study of CRB-913 and Placebo in Obese But Otherwise Healthy Participants, sponsored by Corbus Pharmaceuticals Inc.. Completed at 15 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Corbus Pharmaceuticals Inc. · Phase 1, Interventional, and Treatment
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 254 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Corbus Pharmaceuticals Inc. is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: CRB-913
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.
Drug: CRB-913
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.
Drug: CRB-913
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.
Drug: CRB-913
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.
Drug: Placebo
Administered QD
Administered QD
Part 1: To evaluate the PK of a single dose of CRB-913 - Cmax
Maximum plasma concentration (Cmax)
Time frame: 0 to 48 hours
Part 1: To evaluate the PK of a single dose of CRB-913 - Tmax
Time to maximum plasma concentration (Tmax)
Time frame: 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)
Time frame: 0 to 48 hours
Part 2: To evaluate the safety of CRB-913 - TEAE
Incidence and severity of treatment emergent adverse events
Time frame: 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
Time frame: Day 1 to 28 days post final dose
Part 1: To evaluate the safety of a single dose of CRB-913 - TEAE
Incidence and severity of treatment emergent adverse events
Time frame: 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
Time frame: Day 1 to 28 days post final dose
Part 2: To evaluate the PK of CRB-913 - Cmax
Maximum plasma concentration (Cmax)
Time frame: Day 1 to 28 days post final dose
Part 2: To evaluate the PK of CRB-913 - Tmax
Time to maximum plasma concentration (Tmax)
Time frame: Day 1 to 28 days post final dose
Part 2: To evaluate changes in food noise
Mean change from baseline in food noise questionnaire (FNQ) score
Time frame: Day 1 to 28 days post final dose
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Dec 2025 to primary completion in Aug 2026, 7 months.
Of 334 industry-sponsored phase 1 interventional studies under Obesity, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 15. This study's 7 months is below that.
Counting every sponsor, half of 439 studies reached it within 11 months; a quarter within 6 and three quarters within 24.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 9, 2026: primary completion Jul 2026 → Aug 2026 and completion Jul 2026 → Aug 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Corbus Pharmaceuticals Inc.