Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 for Alcohol Use Disorder (AUD). It is currently in Phase 1 clinical development and is not yet approved by the FDA. The drug is being studied in healthy volunteers to evaluate its safety and tolerability.
DCR-AUD is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials for this investigational drug in the United States.
DCR-AUD is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both involving healthy volunteers, to assess the drug's safety and pharmacokinetics.
DCR-AUD has been studied in two completed Phase 1 clinical trials. The first trial, NCT05021640, enrolled 36 healthy volunteers in the United States. The second trial, NCT05845398, enrolled 16 healthy volunteers. Both trials were randomized, double-blind, and placebo-controlled.
DCR-AUD is a small molecule being developed for Alcohol Use Disorder. The specific molecular target of DCR-AUD has not been disclosed in available information, so its mechanism of action is not publicly detailed.
DCR-AUD is not known to have any alternative names. It is a distinct investigational drug being developed by Novo Nordisk for Alcohol Use Disorder, and no other names have been associated with it in clinical trial records.