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NCT06648655 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Alcohol Use Disorder (AUD), sponsored by Tempero Bio.

Active
Registry status
Phase 2
Development phase
110
Enrollment target
14
Study locations

NCT06648655 is a Phase 2 study of Alcohol Use Disorder (AUD) that is active but no longer recruiting, run by Tempero Bio. The registered enrollment target is 110 participants, below the 1,820-participant average among 30 other Alcohol Use Disorder (AUD) trials with a reported enrollment target (94% lower). The trial reports 14 study locations across 10 states.

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The verdict

NCT06648655, a Phase 2 study of Alcohol Use Disorder (AUD), is active but no longer recruiting, sponsored by Tempero Bio.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
110 participants
Enrollment target
14
Study locations

Study 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.

Conditions Studied

Alcohol Use Disorder (AUD)

Interventions

  • DRUG Placebo
  • DRUG TMP-301

Study Locations (14)

Florida

  • Research Centers of America, LLC - Hollywood
  • CNS Healthcare- Jacksonville South - Jacksonville
  • Segal Trials - West Broward Outpatient Site - Lauderhill
  • CNS Healthcare - Orlando

Georgia

  • CenExcel iResearch - Decatur
  • CenExcel iResearch - Savannah

Arizona

  • Headlands Research - Scottsdale

Connecticut

  • Yale School of Medicine - New Haven

Louisiana

  • DelRicht Research - Murphy Clinic - Mandeville

New Mexico

  • IMA Clinical Research - Albuquerque

New York

  • Neurobehavioral Research, Inc. - Cedarhurst

South Carolina

  • Medical University of South Carolina, Institute of Psychiatry - Charleston

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2024-11-14
Est. Completion 2025-11-15
Phase Phase 2

Sponsor

Tempero Bio

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06648655

The ClinicalTrials.gov registry entry for NCT06648655 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,820-participant average among 30 other Alcohol Use Disorder (AUD) trials with a reported enrollment target (94% lower). The listed sponsor is Tempero Bio, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alcohol Use Disorder (AUD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06648655 reports 14 study locations spanning 10 distinct geographic areas - top geographies include Florida, Georgia, Arizona.

Frequently Asked Questions

What is clinical trial NCT06648655 about?

NCT06648655 is a clinical study titled "A Study to Investigate the Safety and Efficacy of TMP-301 Compared to Placebo in Adult Patients With Alcohol Use Disorder". 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...

What is the current status of trial NCT06648655?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2024-11-14. Estimated completion is 2025-11-15.

What conditions does trial NCT06648655 study?

This clinical trial studies the following conditions: Alcohol Use Disorder (AUD).

What interventions are being tested in trial NCT06648655?

The interventions under investigation include: Placebo (DRUG), TMP-301 (DRUG).

Who is sponsoring clinical trial NCT06648655?

This trial is sponsored by Tempero Bio, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06648655 being conducted?

This trial has 14 study locations across Arizona, Connecticut, Florida, Georgia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.