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The goal of this clinical trial is to test the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of of repeat doses of DCR-AUD in adult healthy volunteers who are social drinkers.
The main questions it aims to answer are:
Participants will:
Researchers will compare the groups of participates who receive study drug with the group of participants who receive placebo to see if the study drug is safe and tolerable and whether the study drug has any real effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. | From Day 1 up to 24 Weeks |
| Number of Participants With Severity Grades of TEAEs | 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. | From Day 1 up to 24 Weeks |
| Number of Participants With Change From Baseline in Clinically Significant Abnormal Vital Signs | Number of participants with change from baseline in clinically significant abnormal vital signs (temperature, pulse rate, respiratory rate, and blood pressure) is presented. |
| Measure | Description | Time Frame |
|---|---|---|
| Six Symptom Responses During Ethanol Interactions Assessments (EIAs) | The degree of aldehyde dehydrogenase 2 (ALDH2) reduction was measured by quantitative assessment of 6 symptom (flushing, headache, palpitations, light-headedness, nausea, and vomiting) responses during EIAs. Each of 6 symptoms was assessed at each of the 4 time points during each EIA. Composite score at each time point was the sum of severity ratings for each of the 6 symptoms. Peak composite score (of the 3 post-alcohol initiation composite scores at each EIA test) was used as the subject's peak score for that EIA test. The point system was as follows: 0 point = symptom not present, 1 point = mild severity of symptom, 2 points = moderate severity of symptom and 3 points = severe severity of symptom. Participants were given a composite score, which was the sum of the scores of all 6 symptoms (highest possible score is 18). |
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Inclusion Criteria:
21 to 65 years, inclusive, at the time of signing informed consent.
Overtly healthy volunteers, as determined by medical evaluation including medical history, physical examination, and laboratory testing.
No diagnosis of AUD within the preceding 12 months per Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
Social drinkers who consume, on average, 5 to 20 drinks per week for men or 5 to 14 drinks per week for women over the 4 weeks prior to Screening, and not more than 8 drinks in a single day.
No evidence of overt or sub-clinical hepatic pathology, as manifest by serologic tests demonstrating hepatic inflammation or compromised hepatic synthetic function (i.e., AST, ALT, GGT, total bilirubin < 1.5 times the ULN at Screening and Day -1).
eGFR ≥ 60 mL/min/1.73 m2 at Screening.
No history of significant adverse reaction(s) to alcohol. Participant should be expected to tolerate the amount of alcohol administered during EIAs.
Willing to participate in up to 10 EIAs.
Has a negative test for SARS-CoV-2 infection on Day -1.
Systolic BP in the range of 80 to 140 mmHg and diastolic BP in the range of 50 to 95 mmHg at Screening. If out of range, BP may be repeated once at the discretion of the Investigator.
Male or female
Male participants with partners of childbearing potential must agree to use contraception from Screening through at least 24 weeks after the last dose of study intervention and refrain from donating sperm during this period (see Section 10.4).
Female participants may not be pregnant or breastfeeding, and at least one of the following conditions must apply:
BMI within the range 18.0 to 32.0 kg/m2 (inclusive).
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion Criteria:
History of any medical condition that may interfere with the metabolism of study intervention or with the clinical and laboratory assessments in this study. 2. History of serious, persistent medical conditions, including liver, gastrointestinal, pulmonary, renal, or cardiovascular abnormalities. 3. History of suicidal attempt at any time or an answer of "yes" on any of the following items in the C-SSRS at Screening:
a. Poorly controlled or unstable hypertension. b. Diabetes mellitus treated with insulin or hypoglycemic agents (including metformin) or HbA1C > 7%. Asthma requiring hospital admission within the preceding 12 months. NOTE: Persons with clinically stable asthma who have not been hospitalized in the prior year and are treated only with orally inhaled medications are not excluded. d. Currently poorly controlled endocrine conditions, except for hypothyroidism that is stable (no treatment change in prior 6 months). e. Significant infection or known systemic inflammatory process ongoing at Screening.
f. History of chronic or recurrent UTI, or UTI within 1 month prior to Screening.
8. History of malignancy within the preceding 5 years requiring treatment, with the exception of excised low grade basal cell skin neoplasms. 9. History of any concomitant medical condition for which alcohol consumption is prohibited or advised against by the participant's physician or health care provider.
10. SARS-CoV-2 infection in the 14 days prior to randomization. 11. Clinically significant illness within the 7 days prior to the first administration of study intervention. History of multiple drug allergies or a history of allergic reaction to an oligonucleotide based therapy.
13. Use of prescription medications (except for hormonal replacement/contraceptive medication for women and inhaled medication for treatment of clinically stable asthma) within 14 days or 5 half-lives (whichever is longer) prior to administration of study intervention. Participants being treated for hypothyroid disease must be on stable treatment (no treatment changes in the preceding 6 months). 14. Receipt of any vaccine (including COVID-19) within 14 days prior to the first administration of study intervention. 15. Regular use of OTC medications, including NSAID (periodic or occasional NSAID use to control temporary pain is not exclusionary). 16. Previously participated in Dicerna Study DCR-AUD-101. 17. Has received an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to dosing or is in follow-up of another clinical study prior to initial dosing with the study intervention. 18. Clinically significant abnormalities in vital signs at Screening: pulse rate (< 40 bpm or > 90 bpm), respiratory rate, or temperature. 19. Clinically significant abnormalities in 12-lead ECG at Screening or predose on Day 1, including QTcF > 470 msec in females and > 450 msec in males. 20. Positive urine drug test at Screening or Day -1. Tests positive for cannabis are not exclusionary. 21. Seropositive for antibodies to HIV, HBV, or HCV at Screening (historical testing may be used if performed within the 3 months prior to screening). NOTE: In participants with previous treatment for hepatitis C with direct-acting HCV medication and seropositivity for HCV, or in participants with prior infection and spontaneous resolution, HCV RNA must be undetectable (at least 2 negative HCV RNA tests at least 12 weeks apart), and the HCV infection must have been resolved or cured > 3 years prior to initial dosing with the investigational medication. 22. Safety laboratory test result at Screening considered clinically unacceptable for study participation by the Investigator. 23. History of intolerance to SC injection(s) or significant abdominal scarring that could potentially hinder study intervention administration or evaluation of local injection site tolerability. 24. Scheduled for an elective surgical procedure during the conduct of this study.
25. Donation of > 500 mL of blood within the 2 months prior to administration of study intervention or donation of plasma within 7 days prior to Screening.
Life Style Considerations:
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| Name | Affiliation | Role |
|---|---|---|
| John Hanrahan, MD, MPH | Dicerna Pharmaceuticals, Inc., a Novo Nordisk company | Study Director |
| Lev G. Gertsik, MD | Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel Los Angeles Early Phase Clinical Unit | Glendale | California | 91206 | United States |
In this trial total 16 healthy participants were randomized in 3:1 ratio to DCR-AUD or placebo.
The study was conducted at 1 site in the United States of America.
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| ID | Title | Description |
|---|---|---|
| FG000 | DCR-AUD | Participant received DCR-AUD 480 mg, subcutaneous injection on Day 1, Day 29 and Day 57. |
| FG001 | Placebo | Participant received DCR-AUD matching placebo, subcutaneous injection on Day 1, Day 29 and Day 57. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Population (SP): All participants randomized to study intervention and who receive at least 1 dose of DCR-AUD or placebo.
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| ID | Title | Description |
|---|---|---|
| BG000 | DCR-AUD | Participant received DCR-AUD 480 mg, subcutaneous injection on Day 1, Day 29 and Day 57. |
| BG001 | Placebo | Participant received DCR-AUD matching placebo, subcutaneous injection on Day 1, Day 29 and Day 57. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. | SP: All participants randomized to study intervention and who receive at least 1 dose of DCR-AUD or placebo. | Posted | Count of Participants | Participants | From Day 1 up to 24 Weeks |
|
From Day 1 until end of the study (24 weeks)
Safety Population (SP): All participants randomized to study intervention and who receive at least 1 dose of DCR-AUD or placebo. All serious and non-serious adverse events presented here are treatment emergent adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DCR-AUD | Participant received DCR-AUD 480 mg, subcutaneous injection on Day 1, Day 29 and Day 57. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Reporting Office (2834) | Dicerna Pharmaceuticals, Inc., a Novo Nordisk company | 866-867-7178 | (+1) | clinicaltrials@novonordisk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 17, 2023 | Oct 24, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2023 | Oct 24, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Participants will be randomized 3 to 1 to DCR-AUD or placebo.
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Participants and site study staff will be blinded to the randomization. Some members of the Sponsor team will be unblinded.
|
|
| Placebo | Drug | 0.9% saline for injection. |
|
| From Baseline (Day -1) up to 24 weeks |
| Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG) | 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. | From Baseline (Day -1) up to 24 weeks |
| Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values | Number of participants with change from baseline in clinically significant abnormal laboratory values (hematology, clinical chemistry, coagulation and routine urinalysis parameters) is presented. | From Baseline (Day -1) up to 24 weeks |
| Number of Participants With Change From Baseline in Clinically Significant Physical Examination Findings | 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. | From Baseline (Day -1) up to 24 weeks |
| Day -1 (baseline), Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 112, Day 140 and Day 168 |
| AUC0-last: Area Under the Plasma Concentration Curve From Time Zero to the Last Quantifiable Concentration of DCR-AUD | AUC0-last is defined as the area under the plasma concentration curve from time zero to the last quantifiable concentration of DCR-AUD. | Day 1, Day 29 and Day 57 |
| Cmax: Maximum Observed Plasma Concentration of DCR-AUD | Cmax is defined as maximum observed plasma concentration of DCR-AUD is presented. | Day 1, Day 29 and Day 57 |
| Tmax: Time to Reach the Maximum Plasma Concentration of DCR-AUD (Cmax) | Tmax is defined as time to reach the maximum plasma concentration (Cmax) of DCR-AUD. | Day 1, Day 29 and Day 57 |
| Cmax: Maximum Observed Plasma Concentration of Acetaldehyde | Maximum observed plasma concentration of acetaldehyde levels was measured to evaluate the pharmacodynamic effects of ALDH2 reduction by DCR-AUD during serial EIAs. | Day -1 (baseline), Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 112, Day 140 and Day 168 |
| AUC0-4: Area Under the Concentration Time Curve From Time 0 to Fixed Time 4 of Acetaldehyde | Area under the concentration time curve from time 0 to fixed time 4 of acetaldehyde levels was measured to evaluate the pharmacodynamic effects of ALDH2 reduction by DCR-AUD during serial EIAs. | Day -1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 112, Day 140 and Day 168 |
| Change From Baseline in Heart Rate | Heart rate is measured to evaluate the PD effects of ALDH2 reduction by DCR-AUD during serial EIA. Heart rate was monitored by telemetry during the EIAs. | Baseline, Day 169 |
| Change From Baseline in Facial Skin Temperature | Change in facial skin temperature was measured to evaluate the PD effects of ALDH2 reduction by DCR-AUD during serial EIAs. | Baseline, Day 169 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | DCR-AUD | Participant received DCR-AUD 480 mg, subcutaneous injection on Day 1, Day 29 and Day 57. |
| OG001 | Placebo | Participant received DCR-AUD matching placebo, subcutaneous injection on Day 1, Day 29 and Day 57. |
|
|
| Primary | Number of Participants With Severity Grades of TEAEs | 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. | SP: All participants randomized to study intervention and who receive at least 1 dose of DCR-AUD or placebo. | Posted | Count of Participants | Participants | From Day 1 up to 24 Weeks |
|
|
|
| Primary | Number of Participants With Change From Baseline in Clinically Significant Abnormal Vital Signs | Number of participants with change from baseline in clinically significant abnormal vital signs (temperature, pulse rate, respiratory rate, and blood pressure) is presented. | SP: All participants randomized to study intervention and who receive at least 1 dose of DCR-AUD or placebo. | Posted | Count of Participants | Participants | From Baseline (Day -1) up to 24 weeks |
|
|
|
| Primary | Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG) | 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. | SP: All participants randomized to study intervention and who receive at least 1 dose of DCR-AUD or placebo. | Posted | Count of Participants | Participants | From Baseline (Day -1) up to 24 weeks |
|
|
|
| Primary | Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values | Number of participants with change from baseline in clinically significant abnormal laboratory values (hematology, clinical chemistry, coagulation and routine urinalysis parameters) is presented. | SP: All participants randomized to study intervention and who receive at least 1 dose of DCR-AUD or placebo. | Posted | Count of Participants | Participants | From Baseline (Day -1) up to 24 weeks |
|
|
|
| Primary | Number of Participants With Change From Baseline in Clinically Significant Physical Examination Findings | 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. | SP: All participants randomized to study intervention and who receive at least 1 dose of DCR-AUD or placebo. | Posted | Count of Participants | Participants | From Baseline (Day -1) up to 24 weeks |
|
|
|
| Secondary | Six Symptom Responses During Ethanol Interactions Assessments (EIAs) | The degree of aldehyde dehydrogenase 2 (ALDH2) reduction was measured by quantitative assessment of 6 symptom (flushing, headache, palpitations, light-headedness, nausea, and vomiting) responses during EIAs. Each of 6 symptoms was assessed at each of the 4 time points during each EIA. Composite score at each time point was the sum of severity ratings for each of the 6 symptoms. Peak composite score (of the 3 post-alcohol initiation composite scores at each EIA test) was used as the subject's peak score for that EIA test. The point system was as follows: 0 point = symptom not present, 1 point = mild severity of symptom, 2 points = moderate severity of symptom and 3 points = severe severity of symptom. Participants were given a composite score, which was the sum of the scores of all 6 symptoms (highest possible score is 18). | Pharmacodynamic Population (PP): All participants randomized to study intervention and who receive at least 1 dose of DCR-AUD or placebo and have at least 1 postdose PD assessment. Here, number analysed signifies participants with available data for each specified timepoints. | Posted | Mean | Standard Deviation | Score on a scale | Day -1 (baseline), Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 112, Day 140 and Day 168 |
|
|
|
| Secondary | AUC0-last: Area Under the Plasma Concentration Curve From Time Zero to the Last Quantifiable Concentration of DCR-AUD | AUC0-last is defined as the area under the plasma concentration curve from time zero to the last quantifiable concentration of DCR-AUD. | Pharmacokinetic Population (PKP): All participants randomized to study intervention and who receive at least 1 dose of DCR-AUD and have at least 1 postdose PK assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per millilitre (h*ng/ mL) | Day 1, Day 29 and Day 57 |
|
|
|
| Secondary | Cmax: Maximum Observed Plasma Concentration of DCR-AUD | Cmax is defined as maximum observed plasma concentration of DCR-AUD is presented. | PKP: All participants randomized to study intervention and who receive at least 1 dose of DCR-AUD and have at least 1 postdose PK assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per millilitre (ng/mL) | Day 1, Day 29 and Day 57 |
|
|
|
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration of DCR-AUD (Cmax) | Tmax is defined as time to reach the maximum plasma concentration (Cmax) of DCR-AUD. | PKP: All participants randomized to study intervention and who receive at least 1 dose of DCR-AUD and have at least 1 postdose PK assessment. | Posted | Median | Full Range | Hours | Day 1, Day 29 and Day 57 |
|
|
|
| Secondary | Cmax: Maximum Observed Plasma Concentration of Acetaldehyde | Maximum observed plasma concentration of acetaldehyde levels was measured to evaluate the pharmacodynamic effects of ALDH2 reduction by DCR-AUD during serial EIAs. | PP: All participants randomized to study intervention and who receive at least 1 dose of DCR-AUD or placebo and have at least 1 postdose PD assessment. Here, number analysed signifies participants with available data for each specified timepoints. | Posted | Mean | Standard Deviation | Micromolar (μM) | Day -1 (baseline), Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 112, Day 140 and Day 168 |
|
|
|
| Secondary | AUC0-4: Area Under the Concentration Time Curve From Time 0 to Fixed Time 4 of Acetaldehyde | Area under the concentration time curve from time 0 to fixed time 4 of acetaldehyde levels was measured to evaluate the pharmacodynamic effects of ALDH2 reduction by DCR-AUD during serial EIAs. | PP: All participants randomized to study intervention and who receive at least 1 dose of DCR-AUD or placebo and have at least 1 postdose PD assessment. Here, number analysed signifies participants with available data for each specified timepoints. | Posted | Mean | Standard Deviation | Micromolar*hours (μM*h) | Day -1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 112, Day 140 and Day 168 |
|
|
|
| Secondary | Change From Baseline in Heart Rate | Heart rate is measured to evaluate the PD effects of ALDH2 reduction by DCR-AUD during serial EIA. Heart rate was monitored by telemetry during the EIAs. | SP: All participants randomized to study intervention and who receive at least 1 dose of DCR-AUD or placebo. | Posted | Mean | Standard Deviation | beats per minute (beats/min) | Baseline, Day 169 |
|
|
|
| Secondary | Change From Baseline in Facial Skin Temperature | Change in facial skin temperature was measured to evaluate the PD effects of ALDH2 reduction by DCR-AUD during serial EIAs. | SP: All participants randomized to study intervention and who receive at least 1 dose of DCR-AUD or placebo. | Posted | Mean | Standard Deviation | degree celsius | Baseline, Day 169 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 11 |
| 12 |
| EG001 | Placebo | Participant received DCR-AUD matching placebo, subcutaneous injection on Day 1, Day 29 and Day 57. | 0 | 4 | 0 | 4 | 3 | 4 |
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Systematic Assessment |
|
| Flushing | Vascular disorders | Systematic Assessment |
|
| Hot flush | Vascular disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Injection site bruising | General disorders | Systematic Assessment |
|
| Injection site erythema | General disorders | Systematic Assessment |
|
| Injection site discolouration | General disorders | Systematic Assessment |
|
| Injection site dryness | General disorders | Systematic Assessment |
|
| Injection site pain | General disorders | Systematic Assessment |
|
| Injection site swelling | General disorders | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property
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