CompletedPhase 2

An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)

United States47 participantsStarted 2019-03-12

Plain-language summary

An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Male and female subjects 18 to 75 years of age
✓. Confirmed diagnosis of acromegaly with either a partial or complete response to protocol defined somatostatin analogue therapy regimens
✓. 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 acromegaly subjects
✕. Prior treatment with paltusotine
✕. Pituitary surgery within 6 months prior to Screening. Subjects receiving radiation therapy may be eligible with some restrictions.
✕. 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
✕. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result
✕. 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

Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level

Timeframe: 13 Weeks

Trial details

NCT IDNCT03789656

SponsorCrinetics Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-08-03

Results submitted2024-09-11

View on ClinicalTrials.gov More Acromegaly trials