NCT06648655

A Study to Investigate the Safety and Efficacy of TMP-301 Compared to Placebo in Adult Patients With Alcohol Use Disorder

A Phase 2, Randomized, Investigator and Participant bLInded, placeBo-controllEd, paRallel-group Study to Investigate the sAfety, Tolerability, and Preliminary Efficacy of TMP-301 TrEatment in Adult Patients With Alcohol Use Disorder (AUD)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Tempero Bio, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

TMP-301 has been shown in preclinical models to reduce consumption of alcohol and other addictive substances. It has been tested in healthy subjects and has been found to be safe and tolerated at doses predicted to be efficacious in alcohol use disorder. This study is being conducted to evaluate the safety, tolerability and efficacy of TMP-301 in patients with alcohol use disorder.

Detailed description

The purpose of this study is to assess the safety, tolerability and effect on alcohol use (number of heavy drinking days) of TMP-301 compared to placebo in patients with alcohol use disorder. This is a placebo-controlled, parallel-group, multicenter clinical study in moderate to severe alcohol use disorder with ≥8 heavy drinking days over the prior 4 weeks at screening. Study participants and investigators will be blinded to study intervention. The study duration will be up to 19 weeks, with a treatment duration of up to 14 weeks. The visit frequency will be weekly.

Conditions

• Alcohol Use Disorder (AUD)

Interventions

Type	Name	Description
DRUG	TMP-301	Daily (QD) x 14 weeks.
DRUG	Placebo	Daily (QD) x 14 weeks.

Timeline

• Start date: 2024-11-14
• Primary completion: 2025-10-13
• Completion: 2025-11-14
• First posted: 2024-10-18
• Last updated: 2026-04-13

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study