Can a new pill silence the ringing in your ears?

NCT ID NCT07777549

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This Phase 2a trial is testing an experimental drug called TRTL-913 to see if it is safe and might help reduce tinnitus, the perception of ringing or buzzing in the ears. The study has two parts: first, healthy adults will receive the drug or a placebo to check safety and how the body processes it; then, adults with tinnitus will receive the drug to evaluate its effect on their symptoms. The goal is to gather early evidence on whether TRTL-913 could be a future treatment for tinnitus.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TRTL-913
What this could lead to
If successful, TRTL-913 could become a new treatment to reduce the perception of tinnitus, offering relief for millions who experience persistent ringing in the ears.
What could go wrong
This is an early-stage trial focused on safety and dosing, so it may not prove effective. The drug could also cause side effects, and results in healthy volunteers may not predict outcomes in tinnitus patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Part A Inclusion Criteria: 1. Healthy male or female adults aged 18 to 64 years (or 65 to 80 years for an elderly cohort, if enrolled), as determined by the investigator. 2. Able and willing to provide written informed consent and comply with all study procedures. 3. Body mass index (BMI) 18.0 to 35.0 kilograms per square meter (kg/m\^2) and body weight greater than (\>) 50 kilogram (kg). 4. Clinically acceptable medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead ECG, as determined by the investigator. 5. QT interval corrected using the Fridericia method (QTcF) of less than or equal to (≤) 450 millisecond (msec) for males or ≤470 msec for females. 6. Nonsmokers or light smokers (\<10 cigarettes/week or equivalent vaping) for at least 3 months before dosing and willing to abstain during confinement. 7. Women of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception throughout the required study period. 8. Male participants must agree to use appropriate contraception and refrain from sperm donation for the required study period. Part B Inclusion Criteria: 1. Male or female adults aged 18 to 64 years. 2. Able and willing to provide written informed consent and comply with study procedures. 3. Diagnosis of subjective, stable, chronic, non-pulsatile tinnitus. 4. Generally healthy aside from tinnitus, with no clinically significant abnormalities on medical history, physical or neurologic examination, vital signs, laboratory tests, or ECG that would interfere with study participation. 5. BMI 18.0 to 35.0 kg/m\^2 and body weight \>50 kg. 6. Willing to discontinue prohibited medications and substances before study treatment and throughout study participation. 7. Women of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception throughout the required study period. 8. Male participants must agree to use appropriate contraception and refrain from sperm donation for the required study period. Exclusion Criteria: Part A Exclusion Criteria: 1. Any clinically significant acute or chronic medical condition that, in the investigator's opinion, could affect participant safety or study assessments. 2. Use of prohibited medications, including moderate or strong cytochrome (CY)P450 inhibitors or inducers, or other prohibited foods or supplements before dosing. 3. History of seizures, epilepsy, significant head injury associated with loss of consciousness, or other conditions or medications that increase seizure risk. 4. Clinically significant cardiovascular disease, clinically significant ECG abnormalities, long QT syndrome, torsade de pointes, or a family history of long QT syndrome or sudden cardiac death. 5. Active infection or clinically significant recent illness before screening or dosing. 6. Positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. 7. Clinically significant hepatic or renal impairment or clinically significant laboratory abnormalities. 8. History of malignancy within the past 10 years (except adequately treated nonmelanoma skin cancer or cervical carcinoma in situ). 9. Current or recent substance or alcohol use disorder or positive drug or alcohol screening. 10. Current or history of clinically significant psychiatric illness or suicidal ideation or behavior that would increase study risk. 11. Pregnant, breastfeeding, or planning pregnancy during the study. Part B Exclusion Criteria: 1. Current use of, or plans to initiate, pharmacologic or non-pharmacologic treatment for tinnitus during the study. 2. Regular night-shift work that could interfere with study assessments. 3. Use of prohibited medications, including moderate or strong CYP450 inhibitors or inducers, or other prohibited foods or supplements before dosing. 4. History of seizures, epilepsy, significant head injury associated with loss of consciousness, or other conditions or medications that increase seizure risk. 5. Clinically significant acute or chronic medical condition that, in the investigator's opinion, could affect participant safety or study assessments. 6. Positive test for HIV, hepatitis B, or hepatitis C. 7. History of malignancy within the past 10 years (except adequately treated nonmelanoma skin cancer or cervical carcinoma in situ). 8. Current or recent substance or alcohol use disorder or positive drug or alcohol screening. 9. Current or history of clinically significant psychiatric illness or suicidal ideation or behavior that would increase study risk. 10. Pregnant, breastfeeding, or planning pregnancy during the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinical Trial Site

    Auckland, New Zealand

    Contact Email: •••••@•••••

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