Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as DCR-A1203
DCR-AUD · 2 trials · 2 indications
An Adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is defined as an AE that begins or that worsens in severity after the study drug has been administered. An SAE is defined as any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly /birth defect, is the other important medical event.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE is defined as an AE that begins or that worsens in severity after the study drug has been administered. As per the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated; Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living; Grade 3: severe or medically significant but not immediately lifethreatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4: life-threatening consequences; urgent treatment indicated; Grade 5: fatal.
Number of participants with change from baseline in clinically significant abnormal vital signs (temperature, pulse rate, respiratory rate, and blood pressure) is presented.
Number of participants with change from baseline in clinically significant abnormal ECG findings (Heart rate, PR interval, QRS interval, QT interval and QT interval using Fridericia's correction \[QTcF\]) is presented.
Number of participants with change from baseline in clinically significant abnormal laboratory values (hematology, clinical chemistry, coagulation and routine urinalysis parameters) is presented.
Number of participants with change from baseline in clinically significant physical examination findings (assessments of the cardiovascular, respiratory, gastrointestinal, neurological, and skin systems and inspection of the injection site) is presented.
DLT is defined as an AE of greater than or equal to (\>=) Grade 3 intensity (CTCAE Version 5.0) in one participant, unless it is clearly the result of a non-study-related event OR any 2 AEs of \>= Grade 2 intensity in the same body system in one participant.
Number of participants with change from baseline in clinically significant abnormal ECG findings (Heart rate, PR interval, QRS interval, QT interval and QT interval using Fridericia's correction \[QTcF\]) is presented.
| Arm | Type | Description |
|---|---|---|
| DCR-AUD | EXPERIMENTAL | Multiple doses of DCR-AUD. Subcutaneous administration of of DCR-AUD. |
| DCR-AUD Placebo | PLACEBO_COMPARATOR | Multiple doses of placebo comparator. Subcutaneous administration of Placebo for DCR-AUD, volume to match active single dose |
| Cohort 1: DCRAUD 80 mg | EXPERIMENTAL | Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1. |
| Cohort 2: DCRAUD 240 mg | PLACEBO_COMPARATOR | Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1. |
| Cohort 3: DCR-AUD 480 mg | EXPERIMENTAL | Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1. |
| Cohort 4: DCR-AUD 960 mg | PLACEBO_COMPARATOR | Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1. |
| Pooled Placebo | EXPERIMENTAL | Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1. |
| Name | Type | Description |
|---|---|---|
| DCR-AUD | DRUG | DCR-A1203, the drug substance of DCR-AUD, is a synthetic double-stranded (hybridized duplex) RNA oligonucleotide conjugated to GalNAc ligands that enable specific hepatic access and update after subcutaneous administration. DCR-AUD is a sterile solution of DCR-A1203 at a concentration of 160 mg/mL in water for injection (WFI). |
| Placebo | DRUG | 0.9% saline for injection. |
| Placebo for DCR-AUD | DRUG | 0.9% saline for injection |
Inclusion Criteria: 1. 21 to 65 years, inclusive, at the time of signing informed consent. 2. Overtly healthy volunteers, as determined by medical evaluation including medical history, physical examination, and laboratory testing. 3. No diagnosis of AUD within the preceding 12 months per Diagnostic...
DCR-AUD is an investigational small molecule being developed by Novo Nordisk A/S for the treatment of alcohol use disorder. It is in Phase 1 clinical development. Both of its completed Phase 1 trials enrolled healthy volunteers rather than patients with alcohol use disorder, and no regulatory approval has been granted.
DCR-AUD is being developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the two Phase 1 trials of DCR-AUD conducted in the United States. The program sits within the psychiatry therapeutic area, targeting alcohol use disorder.
DCR-AUD is in Phase 1 development. Two Phase 1 trials have been completed, and no trials are currently active. Both studies were randomized, double-blind, and placebo-controlled, and together they enrolled 52 healthy volunteers aged 21 years and older in the United States.
DCR-AUD has been studied in two completed Phase 1 trials. NCT05021640 was a Phase 1 study in healthy volunteers that enrolled 36 participants. NCT05845398 was a Phase 1b study in healthy volunteers that enrolled 16 participants. Both were conducted in the United States and both have completed.
DCR-AUD is being developed as a treatment for alcohol use disorder. It is an investigational small molecule and has not been approved for any indication. The completed Phase 1 trials enrolled healthy volunteers rather than individuals diagnosed with alcohol use disorder, so the program remains in early clinical development.
Yes. Both completed Phase 1 trials of DCR-AUD were randomized, double-blind, and placebo-controlled. NCT05021640 enrolled 36 healthy volunteers and NCT05845398, a Phase 1b study, enrolled 16 healthy volunteers. All participants were 21 years of age or older, and both studies were run in the United States.