Active — Not RecruitingPhase 3

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)

United States111 participantsStarted 2021-12-17

Plain-language summary

A randomized, placebo-controlled 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 non-pharmacologically treated acromegaly.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male and female subjects ≥18 years of age
✓. Confirmed diagnosis of acromegaly and either medically naïve, not currently treated, or willing to washout during the study screening period.
✓. 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

✕. Pituitary radiation therapy within 3 years of Screening
✕. Prior treatment with paltusotine
✕. History of ineffective or intolerance to octreotide or lanreotide
✕. 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 With a Biochemical Response in Insulin-like Growth Factor-1 (IGF-1) at the End of the Randomized Control Phase (EOR)

Timeframe: Week 24

Trial details

NCT IDNCT05192382

SponsorCrinetics Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-20

Results submitted2025-10-22

View on ClinicalTrials.gov More Acromegaly trials