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New pill shows promise for controlling acromegaly Long-Term

NCT ID NCT04261712

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Updated 4 times

Summary

This study looks at the long-term safety and effectiveness of an oral medication called paltusotine for people with acromegaly, a condition where the body makes too much growth hormone. About 43 adults who finished a previous related study will take the drug and be monitored for side effects and hormone levels. The goal is to see if paltusotine can safely control the disease over time.

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

43 people

The number who actually took part.

Started

Jan 2020

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 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: 1. Completed one of the parent studies (Acrobat Evolve \[CRN00808-02\] or Acrobat Edge \[CRN00808-03\]) 2. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control 3. Willing to provide signed informed consent Exclusion Criteria: 1. Clinically significant concomitant disease including, but not limited to, cardiovascular disease; moderate or severe renal insufficiency; or significant liver disease (including cirrhosis) 2. Pituitary radiation since completing participation in parent studies 3. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years 4. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab). 5. History of alcohol or substance abuse in the past 12 months 6. Use of any investigational drug (other than paltusotine) within the past 30 days or 5 half-lives, whichever is longer before Screening 7. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study. 8. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities 9. Subjects with symptomatic cholelithiasis 10. Subjects with clinically significant abnormal findings during the Screening Period, and 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

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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, 90095, United States

  • Crinetics Study Site

    Chicago, Illinois, 60611, United States

  • Crinetics Study Site

    Boston, Massachusetts, 02114, United States

  • Crinetics Study Site

    Columbus, Ohio, 43210, United States

  • Crinetics Study Site

    Pittsburgh, Pennsylvania, 15212, United States

  • Crinetics Study Site

    Pittsburgh, Pennsylvania, 15213, United States

  • Crinetics Study Site

    Dallas, Texas, 75231, United States

  • Crinetics Study Site

    Curitiba, Paraná, 80030-110, Brazil

  • Crinetics Study Site

    Rio de Janeiro, 20231, Brazil

  • Crinetics Study Site

    Rio de Janeiro, 21941, Brazil

  • Crinetics Study Site

    São Paulo, 01228, Brazil

  • Crinetics Study Site

    München, 80336, 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

    Belgrade, 11000, Serbia

  • Crinetics Study Site

    Coventry, United Kingdom

  • Crinetics Study Site

    Leeds, LS97TF, United Kingdom

  • Crinetics Study Site 1

    Athens, 11527, Greece

  • Crinetics Study Site 2

    Athens, 11527, Greece

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