Active, not recruitingPhase 1Interventional
What this study 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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionObese But Otherwise Healthy Participants
Full registry criteria
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
Primary outcomes
Part 1: To evaluate the PK of a single dose of CRB-913 - Cmax0 to 48 hoursMaximum plasma concentration (Cmax)
Part 1: To evaluate the PK of a single dose of CRB-913 - Tmax0 to 48 hoursTime to maximum plasma concentration (Tmax)
Part 1: To evaluate the PK of a single dose of CRB-913 - T1/20 to 48 hoursTerminal elimination half-life (T1/2)
Part 2: To evaluate the safety of CRB-913 - TEAEDay 1 to 28 days post final doseIncidence and severity of treatment emergent adverse events
Part 2: To evaluate the safety of CRB-913 - AESIDay 1 to 28 days post final doseIncidence of adverse events of special interest
