NCT06987513已完成2 期
RECLAIM STUDY: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 13
- 主要终点
- Change from baseline in the average number of heavy drinking days per week, with a heavy drinking day defined as 5 or more drinks in the day for men and 4 or more drinks in the day for women, using the TLFB method
研究概览
简要总结
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in the treatment of AUD in subjects with obesity or overweight. After signing the informed consent form, subjects will be screened and if eligible randomized 1:1 to 1 of the following 2 treatment arms:
- Pemvidutide: 2.4 mg SC once weekly
- Placebo: Placebo SC once weekly
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent signed prior to performance of any study procedures
- •Male or female ages 18 to 75 years, inclusive
- •Diagnosis of current AUD of moderate or greater severity according to DSM-5 criteria
- •Reported drinking at least 28 drinks per week if male or 21 drinks per week if female in the 28 days prior to signing the informed consent. This should include at least 3 heavy drinking days per week (defined as ≥ 5 drinks per day for men and ≥ 4 drinks per day for women) Note: Baseline heavy drinking days will be determined by the TFLB method (28-day recall) drinking pattern collected at the initial screening visit
- •Overweight or obesity, defined as BMI ≥ 25 kg/m2
排除标准
- •Presence of clinically significant alcohol withdrawal symptoms, as defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization
- •History of hospitalization for alcohol intoxication or alcohol withdrawal
- •History of alcohol-related disorders including seizures related to alcohol, MalloryWeiss Syndrome, and alcoholic ketoacidosis
- •History and/or current DSM-5 diagnosis of schizophrenia, bipolar disorder, psychotic disorder or other severe psychiatric disorders, unless documented as well-controlled by the Investigator and cleared by the Medical Monitor
- •C-SSRS score indicative of active suicidal thoughts (answering "yes" to any of Questions 2 through 5 on the C-SSRS) in the past 6 months
研究组 & 干预措施
Pemvidutide 2.4 mg
Experimental
干预措施: Pemvidutide (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline in the average number of heavy drinking days per week, with a heavy drinking day defined as 5 or more drinks in the day for men and 4 or more drinks in the day for women, using the TLFB method
时间窗: Week 24
Change from baseline in the average number of heavy drinking days per week
时间窗: Baseline to Weeks 21-24
Change from baseline in the average number of heavy drinking days per week, with a heavy drinking day defined as 5 or more drinks in the day for men and 4 or more drinks in the day for women, using the Timeline Followback (TLFB) method
次要结局
- Absolute change from baseline in average phosphatidylethanol (PEth) levels at Week 24(24 Weeks)
- Proportion of subjects achieving a 2-level reduction in WHO risk drinking level using the TLFB method for the 4-week period comprising Weeks 21 through 24.(Week 24)
- Proportion of subjects achieving a 2-level reduction in WHO risk drinking level(Baseline to Weeks 21-24)
- Absolute change from baseline in average phosphatidylethanol (PEth) levels at Week 24(Baseline to Week 24)
- Change from baseline in average number of drinks per drinking day(Baseline to Weeks 21-24)
- Change from baseline in proportion of subjects achieving no heavy drinking days(Baseline to Weeks 21-24)
- Change from baseline in average percent days completely abstinent(Baseline to Weeks 21-24)
- Change from baseline at Week 24 in average Drinker Inventory of Consequences - Short Inventory of Problems (DrInc-SIP-2R)(Baseline to Week 24)
- Change from baseline at Week 24 in Patient Reported Outcomes Measurement Information System (PROMIS) Negative Alcohol Consequences (NECO) Short Form(Baseline to Week 24)
- Percent changes from baseline in body weight(Baseline to Week 24)
- Percent change from baseline in BMI(Baseline to Week 24)
- Percent change from baseline in waist circumference(Baseline to Week 24)
研究者
研究点 (13)
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