A Study of Brenipatide in Participants With Alcohol Use Disorder

Study acronym: RENEW-ALC-2
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Site details revised at 29 of 116 sites
  2. Eligibility criteria expanded, about 13 words
    • Study sites revised (116)
  3. Site details revised at 3 of 116 sitesv22
  4. Study sites: 117 to 116v21
  5. Eligibility criteria shortened, about 4 wordsv20
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  1. Site details revised at 6 of 117 sitesv19
  2. Site details revised at 13 of 117 sitesv18
  3. Study sites: 119 to 117v17
  4. Study sites: 117 to 119v16
  1. Trial sites expanded: 114 → 117 locationsv15
  2. Site details revised at 1 of 114 sitesv14
  3. Study sites: 115 to 114v13
  4. Study sites: 116 to 115v12
  5. Site details revised at 12 of 116 sitesv11
  6. Study sites: 112 to 116v10
  7. Study sites: 108 to 112v9
  8. Study sites: 125 to 108
    • Eligibility criteria expanded, about 16 words
    v8
  9. Site details revised at 4 of 125 sitesv7
  10. Site details revised at 3 of 125 sitesv6
  11. Site details revised at 4 of 125 sitesv5
  12. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 124 to 125
    • Start date changed from estimate of Dec 2025 to Oct 16, 2025
    v4
  13. Study Status, Referencesv3
  14. Re-verified, no change to tracked fieldsv2
  15. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Eli Lilly
366 trials monitored
See 16 trials at risk
The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with Alcohol Use Disorder (AUD) and hazardous alcohol use. Participation in this study will last approximately 56 weeks.
Trial Details
NCT Number NCT07219953
Lead Sponsor Eli Lilly and Company
Conditions
(from sponsor)		 Alcohol Use Disorder
Related terms Alcoholism
Enrollment 1,100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov