TerminatedPhase 2

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

Stopped: Study was terminated due to serious adverse event (SAE)

United States110 participantsStarted 2024-11-14

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. Seeking treatment for AUD, with a desire to reduce or cease alcohol use at screening.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: Baseline to Week 14

Trial details

NCT IDNCT06648655

SponsorTempero Bio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-13

View on ClinicalTrials.gov More Alcohol Use Disorder (AUD) trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. Seeking treatment for AUD, with a desire to reduce or cease alcohol use at screening.

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria