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Could a pill replace needles for acromegaly?

NCT ID NCT04837040

Disease control Sponsor: Crinetics Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This study tests an oral drug called paltusotine for people with acromegaly, a condition where the body makes too much growth hormone. Participants had their disease under control with standard injections and were randomly assigned to receive either paltusotine or a placebo. The main goal was to see if the pill could keep hormone levels normal over 36 weeks.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

58 people

The number who actually took part.

Started

May 2021

Finished

May 2026

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 years and older

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: 1. Male and female subjects ≥18 years of age 2. Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 ≤1.0×ULN) via stable dose of protocol defined somatostatin receptor ligand therapy 3. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control 4. Willing to provide signed informed consent Exclusion Criteria: 1. Treatment naïve or treatment-withdrawn acromegaly subjects 2. Prior treatment with paltusotine 3. Pituitary surgery within 24 weeks prior to Screening or history of pituitary radiation therapy 4. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years 5. Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer 6. Known history of HIV, hepatitis B, or active hepatitis C 7. History of alcohol or substance abuse in the past 12 months 8. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study 9. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities 10. Subjects with symptomatic cholelithiasis 11. Subjects with clinically significant abnormal findings during the Screening Period, or any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study 12. Subjects currently taking pasireotide LAR (within 24 weeks prior to Screening) or pegvisomant, dopamine agonists (within 12 weeks prior to Screening), or short acting somatostatin analogs (within 12 weeks prior to first dose of study drug)

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Conditions

The condition(s) this trial relates to.

acromegaly

As listed by the trial registrant

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

Acromegaly

Contacts and locations

Locations

  • Crinetics Study Site

    Los Angeles, California, 90048, United States

  • Crinetics Study Site

    Torrance, California, 90502, United States

  • Crinetics Study Site

    Baltimore, Maryland, 21205, United States

  • Crinetics Study Site

    Boston, Massachusetts, 02114, United States

  • Crinetics Study Site

    Philadelphia, Pennsylvania, 19104, United States

  • Crinetics Study Site

    Pittsburgh, Pennsylvania, 15212, United States

  • Crinetics Study Site

    Nashville, Tennessee, 37203, United States

  • Crinetics Study Site

    CABA, Buenos Aires, C1012AAR, Argentina

  • Crinetics Study Site

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1405BCH, Argentina

  • Crinetics Study Site

    Córdoba, X5000, Argentina

  • Crinetics Study Site

    Ghent, 9000, Belgium

  • Crinetics Study Site

    Fortaleza, Ceará, 60430-275, Brazil

  • Crinetics Study Site

    Curitiba, Paraná, 80030-110, Brazil

  • Crinetics Study Site

    Porto Alegre, Rio Grande do Sul, 90410-000, Brazil

  • Crinetics Study Site

    Rio de Janeiro, 20231-092, Brazil

  • Crinetics Study Site

    Rio de Janeiro, 21941-913, Brazil

  • Crinetics Study Site

    Sofia, 1431, Bulgaria

  • Crinetics Study Site

    Bron, 69677, France

  • Crinetics Study Site

    Pessac, 33604, France

  • Crinetics Study Site

    Budapest, 1083, Hungary

  • Crinetics Study Site

    Pécs, 7624, Hungary

  • Crinetics Study Site

    Beersheba, 8410101, Israel

  • Crinetics Study Site

    Petah Tikva, 4941480, Israel

  • Crinetics Study Site

    Roma, 00168, Italy

  • Crinetics Study Site

    San Isidro, Lima region, 15023, Peru

  • Crinetics Study Site

    Bydgoszcz, 85-605, Poland

  • Crinetics Study Site

    Poznan, 60-355, Poland

  • Crinetics Study Site

    Kemerovo, Kemerovo Oblast, 650066, Russia

  • Crinetics Study Site

    Novosibirsk, Novosibirsk Oblast, 630005, Russia

  • Crinetics Study Site

    Novosibirsk, Novosibirsk Oblast, 630087, Russia

  • Crinetics Study Site

    Samara, Samara Oblast, 443041, Russia

  • Crinetics Study Site

    Kazan', Tatarstan Republic, 420097, Russia

  • Crinetics Study Site

    Moscow, 117186, Russia

  • Crinetics Study Site

    Moscow, 119435, Russia

  • Crinetics Study Site

    Moscow, 125008, Russia

  • Crinetics Study Site

    Belgrade, 11000, Serbia

  • Crinetics Study Site

    Sheffield, South Yorkshire, S102JF, United Kingdom

  • Crinetics Study Site

    Coventry, West Midlands, CV2 2DX, United Kingdom

  • Crinetics Study Site

    London, W12 0HS, United Kingdom

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