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New pill could tame rare growth disorder without surgery

NCT ID NCT05192382

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 in 111 adults with acromegaly, a condition causing abnormal growth due to high hormone levels. Participants are not currently on other treatments. The main goal is to see if the drug safely lowers insulin-like growth factor-1 (IGF-1) levels to normal, helping control the disease.

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

111 people

The number who actually took part.

Started

Dec 2021

Finished

Jun 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 either medically naïve, not currently treated, or willing to washout during the study screening period. 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. Pituitary radiation therapy within 3 years of Screening 2. Prior treatment with paltusotine 3. History of ineffective or intolerance to octreotide or lanreotide 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 or previously using pegvisomant or cabergoline (within 16 weeks prior to Screening) or pasireotide LAR (within 24 weeks prior to Screening)

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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

    Aurora, Colorado, 80045, United States

  • Crinetics Study Site

    Boston, Massachusetts, 02114, United States

  • Crinetics Study Site

    Columbus, Ohio, 43210, United States

  • Crinetics Study Site

    Portland, Oregon, 97239, United States

  • Crinetics Study Site

    Philadelphia, Pennsylvania, 19104, United States

  • Crinetics Study Site

    Pittsburgh, Pennsylvania, 15213, United States

  • Crinetics Study Site

    CABA, Buenos Aires, C1012AAR, Argentina

  • Crinetics Study Site

    Buenos Aires, C1405BCH, Argentina

  • Crinetics Study Site

    CABA, 1425, Argentina

  • Crinetics Study Site

    CABA, C1199ABB, Argentina

  • Crinetics Study Site

    Córdoba, X5000, Argentina

  • Crinetics Study Site

    Fortaleza, Ceará, 60430-275, Brazil

  • Crinetics Study Site

    Belo Horizonte, Minas Gerais, 30130100, Brazil

  • Crinetics Study Site

    Curitiba, Paraná, 80030-110, Brazil

  • Crinetics Study Site

    Botucatu, São Paulo, 18618-686, Brazil

  • Crinetics Study Site

    Campinas, São Paulo, 13060-904, Brazil

  • Crinetics Study Site

    Rio de Janeiro, 20231-092, Brazil

  • Crinetics Study Site

    São Paulo, 05403-000, Brazil

  • Crinetics Study Site

    São Paulo, 1228000, Brazil

  • Crinetics Study Site

    Sofia, 1431, Bulgaria

  • Crinetics Study Site

    Guangzhou, Guangdong, 510080, China

  • Crinetics Study Site

    Shijiazhuang, Hebei, 050000, China

  • Crinetics Study Site

    Zhengzhou, Henan, 450000, China

  • Crinetics Study Site

    Wuhan, Hubei, 430030, China

  • Crinetics Study Site

    Changsha, Hunan, 410003, China

  • Crinetics Study Site

    Jinan, Shandong, 250063, China

  • Crinetics Study Site

    Xi’an, Shanxi, 710032, China

  • Crinetics Study Site

    Chengdu, Sichuan, 610041, China

  • Crinetics Study Site

    Hangzhou, Zhejiang, 310009, China

  • Crinetics Study Site

    Marseille, 13395, France

  • Crinetics Study Site

    Pessac, 33604, France

  • Crinetics Study Site

    Toulouse, 31400, France

  • Crinetics Study Site

    Aachen, 52074, Germany

  • Crinetics Study Site

    Berlin, 10117, Germany

  • Crinetics Study Site

    München, 80336, Germany

  • Crinetics Study Site

    München, 81667, Germany

  • Crinetics Study Site

    Würzburg, 97080, Germany

  • Crinetics Study Site

    Athens, 10676, Greece

  • Crinetics Study Site

    Thessaloniki, 54642, Greece

  • Crinetics Study Site

    Budapest, 1062, Hungary

  • Crinetics Study Site

    Budapest, 1083, Hungary

  • Crinetics Study Site

    Pécs, 7624, Hungary

  • Crinetics Study Site

    Bangalore, Karnataka, 560054, India

  • Crinetics Study Site

    Belagavi, Karnataka, 590010, India

  • Crinetics Study Site

    Kochi, Kerala, 682041, India

  • Crinetics Study Site

    Mumbai, Maharashtra, 400012, India

  • Crinetics Study Site

    Chandigarh, 160012, India

  • Crinetics Study Site

    Delhi, 110029, India

  • Crinetics Study Site

    Petah Tikva, 4941492, Israel

  • Crinetics Study Site

    Roma, 00168, Italy

  • Crinetics Study Site

    Bydgoszcz, 85-605, Poland

  • Crinetics Study Site

    Poznan, 60-355, Poland

  • Crinetics Study Site

    Wroclaw, 50-367, Poland

  • Crinetics Study Site

    Barcelona, 08035, Spain

  • Crinetics Study Site

    London, EC1M 6BQ, United Kingdom

  • Crinetics Study Site (b)

    Beijing, Beijing Municipality, 100730, China

  • Crinetics Study Site (b)

    Athens, 11527, Greece

More trials for these conditions

Other studies related to the condition(s) this trial covers.