NCT05192382TerminatedPhase 3
A Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Non-pharmacologically Treated Acromegaly (PATHFNDR-2)
Crinetics Pharmaceuticals Inc.59 sites in 11 countries111 target enrollmentStarted: December 17, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 111
- Locations
- 59
- Primary Endpoint
- Percentage of Participants With a Biochemical Response in Insulin-like Growth Factor-1 (IGF-1) at the End of the Randomized Control Phase (EOR)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
- •Subjects with symptomatic cholelithiasis
- •Subjects with clinically significant abnormal findings during the Screening Period, or 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
- •Subjects currently or previously using pegvisomant or cabergoline (within 16 weeks prior to Screening) or pasireotide LAR (within 24 weeks prior to Screening)
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Paltusotine
Experimental
Intervention: Paltusotine (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With a Biochemical Response in Insulin-like Growth Factor-1 (IGF-1) at the End of the Randomized Control Phase (EOR)
Time Frame: Week 24
A value \>1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Response is defined as an IGF-1 level ≤1.0×ULN based on the average of last 2 measurements.
Secondary Outcomes
- Change in IGF-1 From Baseline to EOT(Baseline to 24 weeks)
- Percentage of Participants Achieving IGF-1 <1.3×ULN at EOR(24 weeks)
- Percentage of Participants With Growth Hormone (GH) Concentration <1 ng/mL at Week 22(Week 22)
- Change From Baseline in Total Acromegaly Symptoms Diary (ASD) Score to EOT(Baseline to 24 weeks)
Investigators
Study Sites (59)
Loading locations...
Similar Trials
Terminated
Phase 3
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of AcromegalyAcromegalyNCT04837040Crinetics Pharmaceuticals Inc.58
Completed
Phase 3
ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2Ulcerative ColitisNCT05507216Abivax S.A.636
Completed
Phase 3
ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1Ulcerative ColitisNCT05507203Abivax S.A.639
Completed
Phase 3
A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia GravisGeneralized Myasthenia GravisNCT02950155Fredrik Piehl47
Completed
Phase 1
An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)Ulcerative ColitisNCT05084261Adiso Therapeutics24