TMP-301 for Alcoholism

Recruiting at 13 trial locations

Overseen By Ella Kleynerman

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Tempero Bio, Inc.

Must not be taking: Stimulants, GLP-1 agonists

Disqualifiers: Seizures, Psychosis, Hypertension, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

Duration: 14 weeks

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants do not use certain medications, including those for substance use disorders and some psychoactive medications. If you are on any of these, you may need to stop taking them before joining the trial. Please discuss your specific medications with the study team to see if they are allowed.

What is the purpose of this trial?

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.

Eligibility Criteria

Adults aged 18-65 with alcohol use disorder who want to reduce or stop drinking can join this trial. They must have had at least 8 heavy drinking days in the last month and be willing to follow study rules. People with blood pressure outside of specified ranges or a BMI not between 18.0 and 40.0 kg/m2 cannot participate.

Inclusion Criteria

I drink 4 or more drinks a day if female, 5 or more if male.

I have signed the consent form and can follow the study rules. I passed a breathalyzer test.

I have had 8 or more heavy drinking days in the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TMP-301 or placebo daily for 14 weeks to assess safety, tolerability, and efficacy in reducing alcohol consumption

14 weeks

14 visits (weekly, in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• TMP-301

Trial Overview The trial is testing TMP-301, which may help reduce alcohol consumption, against a placebo (a substance with no therapeutic effect). Participants will receive either TMP-301 or the placebo to assess its safety and effectiveness in treating alcohol use disorder.

Participant Groups

Group I: TMP-301 Experimental Treatment 1 Intervention

Daily (QD) x 14 weeks.

Group II: Placebo Placebo Group 1 Intervention

Daily (QD) x 14 weeks.

Who Is Running the Clinical Trial?

Tempero Bio, Inc.

Lead Sponsor

Trials

3

Recruited

150+