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

NCT06648655 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: TMP-301-AUD-201
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 14

Brief 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

Alcohol Use Disorder (AUD)

Keywords

AUD; Substance Use Disorders; SUD

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety and tolerability of TMP-301 in patients with alcohol use disorder

  To evaluate the safety and tolerability of TMP-301 in patients with alcohol use disorder by the incidence and severity of Adverse Events

  Baseline to Week 16

• To evaluate the efficacy of TMP-301 in patients with alcohol use disorder as assessed by the Timeline to Followback measurement

  The Timeline Followback (TLFB) instrument/measurement is used as a clinical tool to obtain quantitative estimates of alcohol use.

  Baseline to Week 14

Secondary Outcomes (6)

• To evaluate the effect of TMP-301 on the number of days that alcohol is consumed

  Baseline to Week 14

• To evaluate the effect of TMP-301 on abstinence from alcohol use

  Baseline to Week 14

• To evaluate the effect of TMP-301 on number of no heavy drinking days

  Baseline to Week 14

• To evaluate the effect of TMP-301 on improvement in world health organization risk score

  Baseline to Week 14

• To evaluate plasma TMP-301 concentrations in patients with alcohol use disorder

  Baseline to Week 14

Study Arms (2)

TMP-301

EXPERIMENTAL

Daily (QD) x 14 weeks.

Drug: TMP-301

Placebo

PLACEBO COMPARATOR

Daily (QD) x 14 weeks.

Drug: Placebo

Interventions

TMP-301 DRUG

Daily (QD) x 14 weeks.

TMP-301

Placebo DRUG

Daily (QD) x 14 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated Informed Consent Form (ICF) with a stated willingness to comply with all study procedures and availability for the duration of the study. A breathalyzer test must be \<0.05% at the time of ICF signing. Participants who have a blood alcohol content between 0.02 and 0.04% inclusive at Screening will be assessed for competency to consent using the UBACC scale. Participants must have a passing score of ≥ 15 during the Screening period to consent and be eligible for randomization.
• Adult female or male, 18 to 65 years of age inclusive, at the time of screening.
• Alcohol use disorder, moderate or severe by DSM-5 diagnostic criteria (i.e., ≥4 out of 11 symptoms present using the SCID-5-CT diagnostic interview) at screening for the previous 12 months.
• At least 8 heavy drinking days over the previous 4 weeks (by Timeline Follow Back) at screening.
• Heavy Drinking Days (HDD): ≥4 drinks/day for females, ≥5 drinks/ day for males.
• A standard drink is defined as 12 ounces (350 ml) of 5% beer, 5 ounces (150 ml) of 12% wine, or 1.5 ounces (44 ml) of 80-proof (40%) distilled spirits.
• Seeking treatment for AUD, with a desire to reduce or cease alcohol use at screening.
• Breathalyzer \<0.05% at baseline..
• BMI of ≥18.0 to ≤40.0 kg/m2 at screening.
• No clinically significant findings (in the investigator's opinion) on physical exam, ECG, vital signs, or clinical laboratory tests at screening. The following criteria must be met:
• Systolic Blood Pressure (SBP) 90-140 mmHg, and Diastolic Blood Pressure (DBP) 50-90 mmHg, inclusive (average of three readings) at screening and baseline.
• Alanine transaminase (ALT) and Aspartate transferase (AST) \< 3x upper limit of normal, and total bilirubin \< upper limit of normal (isolated elevated total bilirubin is allowed if Gilbert's syndrome is the suspected etiology)..
• Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73 m2
• Negative urine drug screen for cocaine or stimulants at screening and baseline
• Able to communicate well and understand written instructions.

You may not qualify if:

• History of hypersensitivity to TMP-301 or other mGluR5 antagonists.
• Evidence of suicidal risk as assessed by the Columbia-Suicide Severity Rating Scale at screening or baseline as follows:
• Suicidal Ideation Section: "Yes" on item 4 or 5 if within 6 months of screening or between screening and baseline.
• Suicidal Behavior Section: "Yes" on any item (except non-suicidal self-injurious behavior) if within 2 years of screening or between screening and baseline.
• Significant risk of acute alcohol withdrawal syndrome (either of the following):
• Any history of Delirium Tremens or seizures from alcohol withdrawal.
• Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) score \>7 at screening or baseline.
• Any history of seizures, except febrile seizures as a child.
• Other (non-alcohol) substance use disorders (by DSM-5) as follows:
• Any cocaine or stimulant use disorder
• Moderate or severe use disorder of all other substances (mild allowed).
• Use of the following within the last 90 days or ≥ 5 times the half-life prior to randomization:
• Pharmacotherapy for any substance use disorder (e.g.: disulfiram, acamprosate, modafinil, topiramate, or baclofen).
• Use of prescribed methylphenidate or other stimulant.
• Use of any Glucagon-like peptide 1 (GLP-1) agonist for any indication.

Sponsors & Collaborators

• Tempero Bio, Inc.: lead

Study Sites (14)

Headlands Research

Scottsdale, Arizona, 85260, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06511, United States

Location

Research Centers of America, LLC

Hollywood, Florida, 33024, United States

Location

CNS Healthcare- Jacksonville South

Jacksonville, Florida, 32256, United States

Location

Segal Trials - West Broward Outpatient Site

Lauderhill, Florida, 33311, United States

Location

CNS Healthcare

Orlando, Florida, 32801, United States

Location

CenExcel iResearch

Decatur, Georgia, 30030, United States

Location

CenExcel iResearch

Savannah, Georgia, 31405, United States

Location

DelRicht Research - Murphy Clinic

Mandeville, Louisiana, 70448, United States

Location

IMA Clinical Research

Albuquerque, New Mexico, 87109, United States

Location

Neurobehavioral Research, Inc.

Cedarhurst, New York, 11516, United States

Location

Medical University of South Carolina, Institute of Psychiatry

Charleston, South Carolina, 29425, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Virginia: Center for Leading Edge Addiction Research

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 18, 2024
• Study Start: November 14, 2024
• Primary Completion: October 13, 2025
• Study Completion: November 14, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)