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New asthma pill shows promise in Mid-Stage trial

NCT ID NCT07323654

Disease control Sponsor: Kymera Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Aug 18, 2026 · Updated 5 times

Summary

This study tests an oral drug called KT-621 in 264 adults with moderate to severe eosinophilic asthma that is not well controlled by current treatments. Participants will take either KT-621 or a placebo daily for several weeks. Researchers will measure changes in lung function and asthma control to see if the drug is safe and effective.

What this could mean

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

Active substance
KT-621 (oral drug)
What this could lead to
If successful, this could lead to a new daily pill to better control eosinophilic asthma, reducing symptoms and improving lung function.
What could go wrong
This is a mid-stage trial with only 264 people, so results may not apply to everyone. The drug may not work better than placebo or could have side effects.

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 264 people

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

Started

Jan 2026

Expected to finish

Dec 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 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Must be 18 years old (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age, inclusive, at the time of signing the ICF. * Must have a physician diagnosis of asthma for at least 1 year prior to the Screening visit. * Must be on a stable regimen of medium- to high- dose inhaled corticosteroid (ICS), in combination with a long-acting β2-agonist (LABA). The regimen may include additional controller medications used for at least 12 weeks, at a stable dose and regimen, with no change in the dose or frequency of administration for at least 4 weeks prior to the Screening visit and between the Screening and Baseline visits. * Must have a pre-bronchodilator FEV1 40 to 80% of predicted normal at the Screening and Baseline visits, prior to randomization. * Must have an ACQ-5 score ≥ 1.5 at the Screening and Baseline visits, prior to randomization. * Must have a FeNO level of ≥ 25 ppb at the Screening and Baseline visits. * Must have a demonstrated evidence of reversible airway obstruction by post-bronchodilator (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL at Screening. * Must have an absolute blood eosinophil count must be ≥ 0.30 × 10\^9/L at Screening. * Must have a documented history of at least 1 asthma exacerbation requiring either treatment with systemic corticosteroids (intramuscular, intravenous, or oral) and/or hospitalization or an emergency/urgent medical care visit for acute asthma worsening within the past 52 weeks prior to Screening. * Must agree to contraceptive requirements in compliance with the clinical study and local requirements. * Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, other study-related procedures, and questionnaires, including completing the electronic diary (e-diary), for the duration of the study as required by the study protocol. Exclusion Criteria: * Must not have any clinically significant pulmonary disease other than asthma. * Must not have had an asthma exacerbation, requiring either treatment with systemic corticosteroids (intramuscular, intravenous, or oral) and/or hospitalization or an emergency/urgent medical care visit for acute asthma worsening, at any time from 4 weeks prior to the Screening visit up to and including the Baseline visit. * Must not have any other clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with participant safety, study evaluations, and/or study procedures. * Must not be pregnant or breastfeeding; must not be a woman planning to become pregnant or breastfeed during the study. * Must not have results from clinical laboratory safety tests that are outside the local reference range at Screening. * Must not have been dosed with any investigational drug or device in a clinical study within 8 weeks or 5 half-lives (whichever is longer) of KT-621 administration. * Must not have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results. * Must not be a current smoker of nicotine/tobacco as well as non-nicotine products, have a smoking history of ≥ 10 pack years, or use vaping products, including electronic cigarettes. Former smokers with a smoking history of \< 10 pack years and users of vaping or e-cigarette products must have stopped for at least 26 weeks prior to the Screening visit. * Must not have a known sensitivity to any of the components of KT-621. * Must not be a member of the investigational team or his/her immediate family.

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Conditions

The condition(s) this trial relates to.

pulmonary eosinophilia T2-high asthma

As listed by the trial registrant

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

Eosinophilic asthma

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

    71 sites in 10 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Kymera Investigative Site

    RECRUITING

    Lancaster, California, 93534, United States

  • Kymera Investigative Site

    RECRUITING

    Long Beach, California, 90815, United States

  • Kymera Investigative Site

    RECRUITING

    Northridge, California, 91324, United States

  • Kymera Investigative Site

    RECRUITING

    Redding, California, 96001, United States

  • Kymera Investigative Site

    RECRUITING

    San Francisco, California, 94112, United States

  • Kymera Investigative Site

    RECRUITING

    Upland, California, 91786, United States

  • Kymera Investigative Site

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Kymera Investigative Site

    RECRUITING

    New Haven, Connecticut, 06519, United States

  • Kymera Investigative Site

    RECRUITING

    Loxahatchee Groves, Florida, 33470, United States

  • Kymera Investigative Site

    RECRUITING

    Miami, Florida, 33126, United States

  • Kymera Investigative Site

    RECRUITING

    Miami, Florida, 33173, United States

  • Kymera Investigative Site

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • Kymera Investigative Site

    RECRUITING

    Orlando, Florida, 32819, United States

  • Kymera Investigative Site

    RECRUITING

    Tampa, Florida, 33607, United States

  • Kymera Investigative Site

    RECRUITING

    East Point, Georgia, 30344, United States

  • Kymera Investigative Site

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Kymera Investigative Site

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Kymera Investigative Site

    RECRUITING

    Louisville, Kentucky, 40217, United States

  • Kymera Investigative Site

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Kymera Investigative Site

    RECRUITING

    Chapel Hill, North Carolina, 27517, United States

  • Kymera Investigative Site

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Kymera Investigative Site

    RECRUITING

    Toledo, Ohio, 43617, United States

  • Kymera Investigative Site

    RECRUITING

    Edmond, Oklahoma, 73034, United States

  • Kymera Investigative Site

    RECRUITING

    Clackamas, Oregon, 97015, United States

  • Kymera Investigative Site

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • Kymera Investigative Site

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Kymera Investigative Site

    RECRUITING

    Pittsburgh, Pennsylvania, 15241, United States

  • Kymera Investigative Site

    RECRUITING

    North Charleston, South Carolina, 29406, United States

  • Kymera Investigative Site

    RECRUITING

    Rock Hill, South Carolina, 29732, United States

  • Kymera Investigative Site

    RECRUITING

    Chattanooga, Tennessee, 37403, United States

  • Kymera Investigative Site

    RECRUITING

    Dallas, Texas, 75209, United States

  • Kymera Investigative Site

    RECRUITING

    Dallas, Texas, 75246, United States

  • Kymera Investigative Site

    RECRUITING

    McKinney, Texas, 75069, United States

  • Kymera Investigative Site

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Kymera Investigative Site

    RECRUITING

    Buenos Aires, Argentina

  • Kymera Investigative Site

    RECRUITING

    Concepción del Uruguay, Argentina

  • Kymera Investigative Site

    RECRUITING

    Rosario, Argentina

  • Kymera Investigative Site

    RECRUITING

    San Miguel de Tucumán, Argentina

  • Kymera Investigative Site

    RECRUITING

    Berlin, Germany

  • Kymera Investigative Site

    RECRUITING

    Leipzig, Germany

  • Kymera Investigative Site

    RECRUITING

    Bialystok, Poland

  • Kymera Investigative Site

    RECRUITING

    Gdansk, Poland

  • Kymera Investigative Site

    RECRUITING

    Lodz, Poland

  • Kymera Investigative Site

    RECRUITING

    Poznan, Poland

  • Kymera Investigative Site

    RECRUITING

    Sosnowiec, Poland

  • Kymera Investigative Site

    RECRUITING

    Tarnów, Poland

  • Kymera Investigative Site

    RECRUITING

    Trzebnica, Poland

  • Kymera Investigative Site

    RECRUITING

    Wroclaw, Poland

  • Kymera Investigative Site

    RECRUITING

    Zawadzkie, Poland

  • Kymera Investigative Site

    RECRUITING

    Brasov, Romania

  • Kymera Investigative Site

    RECRUITING

    Craiova, Romania

  • Kymera Investigative Site

    RECRUITING

    Timișoara, Romania

  • Kymera Investigative Site

    RECRUITING

    Belgrade, 11000, Serbia

  • Kymera Investigative Site

    RECRUITING

    Belgrade, Serbia

  • Kymera Investigative Site

    RECRUITING

    Kamenitz, 21204, Serbia

  • Kymera Investigative Site

    RECRUITING

    Užice, 31000, Serbia

  • Kymera Investigative Site

    RECRUITING

    Bardejov, Slovakia

  • Kymera Investigative Site

    RECRUITING

    Košice, Slovakia

  • Kymera Investigative Site

    RECRUITING

    Spišská Nová Ves, Slovakia

  • Kymera Investigative Site

    RECRUITING

    Seoul, South Korea

  • Kymera Investigative Site

    RECRUITING

    Cadiz, Spain

  • Kymera Investigative Site

    RECRUITING

    Jerez de la Frontera, Spain

  • Kymera Investigative Site

    RECRUITING

    Madrid, Spain

  • Kymera Investigative Site

    RECRUITING

    Mataró, Spain

  • Kymera Investigative Site

    RECRUITING

    Santander, Spain

  • Kymera Investigative Site

    RECRUITING

    Bedford, MK40 2FG, United Kingdom

  • Kymera Investigative Site

    RECRUITING

    Birmingham, United Kingdom

  • Kymera Investigative Site

    RECRUITING

    Bristol, United Kingdom

  • Kymera Investigative Site

    RECRUITING

    Leicester, United Kingdom

  • Kymera Investigative Site

    RECRUITING

    London, United Kingdom

  • Kymera Investigative Site

    RECRUITING

    Wythenshawe, United Kingdom

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