Active — Not RecruitingPhase 3

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly

United States58 participantsStarted 2021-05-12

Plain-language summary

A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male and female subjects ≥18 years of age
✓. Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 ≤1.0×ULN) via stable dose of protocol defined somatostatin receptor ligand therapy
✓. 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

✕. Treatment naïve or treatment-withdrawn acromegaly subjects
✕. Prior treatment with paltusotine
✕. Pituitary surgery within 24 weeks prior to Screening or history of pituitary radiation therapy
✕. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
✕. Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
✕. Known history of HIV, hepatitis B, or active hepatitis C
✕. History of alcohol or substance abuse in the past 12 months
✕. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study

What they're measuring

Percentage of Participants Who Maintain Biochemical Response in IGF-1 (≤1.0× the Upper Limit of Normal [ULN]) at the End of the Randomized Control Phase (EOR)

Timeframe: 36 Weeks

Trial details

NCT IDNCT04837040

SponsorCrinetics Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-10

Results submitted2025-10-22

View on ClinicalTrials.gov More Acromegaly trials