A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)
Eli Lilly and Company
Summary
The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with moderate-to-severe Alcohol Use Disorder (AUD). Participation in this study will last approximately 56 weeks.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must be a minimum of 20 years of age for the investigative sites in Japan. * Are seeking treatment and are motivated to stop or cut down on drinking. * Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as * self-inject study intervention * store and use the provided blinded study intervention, as directed * maintain electronic and paper study diaries, as applicable, and * complete the required questionnaires. Excl…
Interventions
- DrugLY3537031
Administered SC
- DrugPlacebo
Administered SC
Locations (119)
- Parkway Medical CenterBirmingham, Alabama
- Headlands Research - ScottsdaleScottsdale, Arizona
- Woodland International Research GroupLittle Rock, Arkansas
- UCLA Clinical & Translational Research Center (CTRC)Los Angeles, California
- Artemis Institute for Clinical ResearchSan Diego, California
- UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission BaySan Francisco, California