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 range18 Years – 65 Years

SexALL

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.
✓. 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:

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 range18 Years – 65 Years

SexALL

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.
✓. 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:

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

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

What they're measuring

Trial details

Exclusion criteria