Active — Not RecruitingPhase 2

A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)

United States43 participantsStarted 2020-01-29

Plain-language summary

A phase 2, open label, long-term extension study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Completed one of the parent studies (Acrobat Evolve \[CRN00808-02\] or Acrobat Edge \[CRN00808-03\])
✓. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
✓. Willing to provide signed informed consent

Exclusion criteria

✕. Clinically significant concomitant disease including, but not limited to, cardiovascular disease; moderate or severe renal insufficiency; or significant liver disease (including cirrhosis)
✕. Pituitary radiation since completing participation in parent studies
✕. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
✕. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab).
✕. History of alcohol or substance abuse in the past 12 months
✕. Use of any investigational drug (other than paltusotine) within the past 30 days or 5 half-lives, whichever is longer before Screening
✕. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study.
✕. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities

What they're measuring

Incidence of treatment-emergent adverse events (TEAEs) throughout the study

Timeframe: Week 316

Trial details

NCT IDNCT04261712

SponsorCrinetics Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-03

View on ClinicalTrials.gov More Acromegaly trials