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Alcohol Use Disorder (AUD)Phase 2LIBERATE-ANCT06648655

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 testing TMP-301 in people with Alcohol Use Disorder (AUD), run by Tempero Bio, Inc. at 14 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Alcohol Use Disorder (AUD)
What is being tested?
TMP-301
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
14 sitesUnited States
Study dates
14 Nov 2024to 14 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Agree to practice highly effective birth control starting at screening and continuing for 30 days (females) or 90 days (males) after study treatment ends.
  • For females any of the following (no donation of eggs/ova is allowed):
  • Abstinence from heterosexual intercourse.
  • Postmenopausal: absence of menses ≥ 12 months (without an alternative medical condition) and Follicle-Stimulating Hormone (FSH) ≥ 40 mIU/mL at screening.
  • Surgically sterile: bilateral oophorectomy, salpingectomy, tubal ligation, or hysterectomy ≥180 days prior to screening.
  • Contraceptive implant or intrauterine device.
  • For males any of the following (no donation of sperm is allowed):
  • Abstinence from heterosexual intercourse.
  • Male condom with spermicide or male condom with vaginal spermicide (gel, foam, or suppository).
  • Surgically sterile: post vasectomy or bilateral orchiectomy

Who cannot join

  • 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.
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  • 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.
  • Past or current history of any mental, behavioral, or neurodevelopmental disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or significant risk of developing a psychosis (assessed by PRIME screen) or a personal history of psychotic symptoms (hallucinations or delusions) with or without a formal psychiatric diagnosis.
  • Individuals with AUD or mild other substance use disorder (except for cocaine or stimulants) may participate.
  • Individuals who meet criteria for a current major depressive episode are excluded.
  • Requires treatment with any psychoactive medications, including any anti-seizure medications (except medications used for short-term treatment of insomnia).
  • Antidepressant medications are allowed if the patients have been on an adequate and stable dose for at least 3 months prior to study treatment dosing with the exception of CYP1A2 substrates or CYP3A4 inhibitors as detailed in Exclusion 19.
  • Having had initiation of, or change in intensity of, psychotherapy or other non-drug therapies within 6 weeks prior to enrollment or unwillingness to maintain current psychotherapeutic and non-drug therapy levels from screening through the or at any time during the acute treatment phase of the study.
  • Use of other investigational drugs or devices at the time of screening, or within 5 half-lives of randomization, or within 30 days, whichever is longer or has been part of any clinical study within 30 days of randomization.
  • Pregnant or nursing (lactating) females.
  • Recent history or active clinically significant manifestations of metabolic, hepatic, renal (including porphyria), hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, neurological, ophthalmic, or ears, nose, and throat (ENT) disorders, or any other acute or chronic condition or medication use that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.
  • Concomitant use of agents known to prolong the QT interval unless these can be permanently discontinued for the duration of study.
  • History or current diagnosis of ECG abnormalities at screening indicating significant risk of safety for subjects participating in the study such as:
  • Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second- or third-degree Atrioventricular (AV) block without a pacemaker.
  • History of familial long QT syndrome or known family history of Torsades de Pointes.
  • QTcF > 450 msec (males); QTcF > 460 msec (females).
  • Note: sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are not exclusionary.
  • Patients with history of chronic hypertension, unless well controlled by taking antihypertensive treatment at a stable dose for ≥3 months
  • History or presence of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there was evidence of local recurrence or metastases.
  • Detectable hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV) antibody at screening.
  • Participants in remission for HCV or HIV, as demonstrated by a sustained virological response (undetectable viral load) may be enrolled in the study.
  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
  • Need/plan to take or substrates of cytochrome P450 (CYP)1A2 or inhibitors of CYP3A4. (Note: CYP1A2 inhibitors are permitted, as they are not expected to increase TMP-301 exposures above what was shown to be safe and generally well-tolerated in study TMP-301- HNV-101.).
  • CYP1A2 Substrates: (Exposure could increase when taken with TMP-301):
  • alosetron, duloxetine, melatonin, ramelteon, tasimelteon, tizanidine, pimozide, agomelatine, tacrine, clozapine, pirfenidone, theophylline, tacrine, ropivacaine
  • CYP3A4 Inhibitors: Could increase TMP-301 exposure at steady- state
  • grapefruit juice, Seville orange-containing food (e.g. bitter orange marmalade) or drink (e.g. bitter orange liqueurs including Curaçao and Grand Marnier)
  • ketoconazole, diltiazem, verapamil, clarithromycin, itraconazole, erythromycin, fluconazole, ceritinib, cobicistat, idelalisib, indinavir. ritonavir, nefazodone, lopinavir, aprepitant, ciprofloxacin, conivaptan, crizotinib, dronedarone, imatinib
  • Patient cannot:
  • Anticipate any significant problems with transportation arrangements or available time to travel to the study site and have any plans to move within the next months to a location which would make continued participation in the study' impractical.
  • Be involved in any unresolved legal problems that could jeopardize continuation or completion of the study.
  • Have any pending charges for violent crime (not including Driving Under the Influence (DUI) offenses).
  • Have any court case with a pending decision that could prohibit participation or compliance in the study.
  • Living situation precludes an ability to adhere to study visits in the opinion of the investigator.
  • Has been previously treated in this study or randomized or treated in any other study employing TMP-301 (i.e., subject may not have received study drug and then reenrolled).
  • Any condition not identified in the protocol that in the opinion of the investigator would confound the evaluation and interpretation of the study data or may put the subject at risk.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • IMA Clinical Research

    Albuquerque, New Mexico, 87109

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York, 11516

  • Medical University of South Carolina, Institute of Psychiatry

    Charleston, South Carolina, 29425

  • University of Virginia: Center for Leading Edge Addiction Research

    Charlottesville, Virginia, 22903

  • CenExcel iResearch

    Decatur, Georgia, 30030

  • Research Centers of America, LLC

    Hollywood, Florida, 33024

  • Baylor College of Medicine

    Houston, Texas, 77030

  • CNS Healthcare- Jacksonville South

    Jacksonville, Florida, 32256

  • Segal Trials - West Broward Outpatient Site

    Lauderhill, Florida, 33311

  • DelRicht Research - Murphy Clinic

    Mandeville, Louisiana, 70448

  • Yale School of Medicine

    New Haven, Connecticut, 06511

  • CNS Healthcare

    Orlando, Florida, 32801

  • CenExcel iResearch

    Savannah, Georgia, 31405

  • Headlands Research

    Scottsdale, Arizona, 85260

Other trials in United States

About this study

Official title: 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)

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.

Read the 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.

Being tested
TMP-301, Placebo
Keywords
AUD, Substance Use Disorders, SUD
Medical subject headings
Alcoholism, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TMP-301Drug

    Daily (QD) x 14 weeks.

  • PlaceboDrug

    Daily (QD) x 14 weeks.

Study groups in NCT06648655
Study groupRoleWhat they receive
TMP-301ExperimentalDaily (QD) x 14 weeks.
Receives: Drug: TMP-301
PlaceboPlacebo comparatorDaily (QD) x 14 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline to Week 16

  2. 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.

    Measured: Baseline to Week 14

Secondary outcomes (6)

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

    Measured: Baseline to Week 14

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

    Subjects will be asked if they have consumed alcohol.

    Measured: Baseline to Week 14

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

    Subjects will be asked about heavy drinking days, defined as ≥4 drinks/day for females, ≥5 drinks/day for males.

    Measured: Baseline to Week 14

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

    Measured: Baseline to Week 14

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

    To evaluate Ctrough of TMP-301 concentrations in patients with alcohol use disorder

    Measured: Baseline to Week 14

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

    To evaluate C2hr of TMP-301 concentrations in patients with alcohol use disorder

    Measured: Baseline to Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2024
  2. Study start14 Nov 2024
  3. Primary completion13 Oct 2025
  4. Study completion14 Nov 2025

Why it stopped: Study was terminated due to serious adverse event (SAE)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06648655
Sponsor's protocol ID
TMP-301-AUD-201
Acronym
LIBERATE-A
Status last verified
Apr 2026
First submitted
10 Oct 2024
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TMP-301 in people with Alcohol Use Disorder (AUD), run by Tempero Bio, Inc. at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study was terminated due to serious adverse event (SAE)). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety and tolerability of TMP-301 in patients with alcohol use disorder (time frame: Baseline to Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06648655.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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