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

NCT04837040 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 3 other identifiers: CRN00808-092020-005431-702024-511925-71-00
• Study Type: interventional
• Target: 58
• Locations: 14 countries
• Sites: 39

Brief 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.

Conditions

Acromegaly

Keywords

Acromegaly; PATHFNDR; Paltusotine; CRN00808

Outcome Measures

Primary Outcomes (1)

• 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)

  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 (weeks 34 and 36).

  36 Weeks

Secondary Outcomes (3)

• Change From Baseline in IGF-1 to EOR

  Baseline to 36 Weeks

• Percentage of Participants With GH <1.0 ng/mL at Week 34

  Week 34

• Change From Baseline in Total Acromegaly Symptoms Diary (ASD) Score to EOR

  Baseline to 36 Weeks

Study Arms (2)

Paltusotine

EXPERIMENTAL

Drug: Paltusotine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Paltusotine DRUG

Paltusotine, tablets, once daily by mouth

Also known as: CRN00808

Paltusotine

Placebo DRUG

Placebo, tablets, once daily by mouth

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Treatment naïve or treatment-withdrawn acromegaly subjects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
• 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 taking pasireotide LAR (within 24 weeks prior to Screening) or pegvisomant, dopamine agonists (within 12 weeks prior to Screening), or short acting somatostatin analogs (within 12 weeks prior to first dose of study drug)

Sponsors & Collaborators

• Crinetics Pharmaceuticals Inc.: lead

Study Sites (39)

Crinetics Study Site

Los Angeles, California, 90048, United States

Location

Crinetics Study Site

Torrance, California, 90502, United States

Location

Crinetics Study Site

Baltimore, Maryland, 21205, United States

Location

Crinetics Study Site

Boston, Massachusetts, 02114, United States

Location

Crinetics Study Site

Philadelphia, Pennsylvania, 19104, United States

Location

Crinetics Study Site

Pittsburgh, Pennsylvania, 15212, United States

Location

Crinetics Study Site

Nashville, Tennessee, 37203, United States

Location

Crinetics Study Site

CABA, Buenos Aires, C1012AAR, Argentina

Location

Crinetics Study Site

Ciudad Autonoma de Buenos Aire, Buenos Aires, C1405BCH, Argentina

Location

Crinetics Study Site

Córdoba, X5000, Argentina

Location

Crinetics Study Site

Ghent, 9000, Belgium

Location

Crinetics Study Site

Fortaleza, Ceará, 60430-275, Brazil

Location

Crinetics Study Site

Curitiba, Paraná, 80030-110, Brazil

Location

Crinetics Study Site

Porto Alegre, Rio Grande do Sul, 90410-000, Brazil

Location

Crinetics Study Site

Rio de Janeiro, 20231-092, Brazil

Location

Crinetics Study Site

Rio de Janeiro, 21941-913, Brazil

Location

Crinetics Study Site

Sofia, 1431, Bulgaria

Location

Crinetics Study Site

Bron, 69677, France

Location

Crinetics Study Site

Pessac, 33604, France

Location

Crinetics Study Site

Budapest, 1083, Hungary

Location

Crinetics Study Site

Pécs, 7624, Hungary

Location

Crinetics Study Site

Beersheba, 8410101, Israel

Location

Crinetics Study Site

Petah Tikva, 4941480, Israel

Location

Crinetics Study Site

Roma, 00168, Italy

Location

Crinetics Study Site

San Isidro, Lima region, 15023, Peru

Location

Crinetics Study Site

Bydgoszcz, 85-605, Poland

Location

Crinetics Study Site

Poznan, 60-355, Poland

Location

Crinetics Study Site

Kemerovo, Kemerovo Oblast, 650066, Russia

Location

Crinetics Study Site

Novosibirsk, Novosibirsk Oblast, 630005, Russia

Location

Crinetics Study Site

Novosibirsk, Novosibirsk Oblast, 630087, Russia

Location

Crinetics Study Site

Samara, Samara Oblast, 443041, Russia

Location

Crinetics Study Site

Kazan', Tatarstan Republic, 420097, Russia

Location

Crinetics Study Site

Moscow, 117186, Russia

Location

Crinetics Study Site

Moscow, 119435, Russia

Location

Crinetics Study Site

Moscow, 125008, Russia

Location

Crinetics Study Site

Belgrade, 11000, Serbia

Location

Crinetics Study Site

Sheffield, South Yorkshire, S102JF, United Kingdom

Location

Crinetics Study Site

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

Crinetics Study Site

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Clinical Research Director
• Organization: Crinetics Pharmaceuticals, Inc.

medinfo@crinetics.com

(833) 276-4636

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: May 12, 2021
• Primary Completion: July 10, 2023
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 2, 2026
• Results First Posted: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); PE (1); AR (3); IT (1); BR (5); BU (1); US (7); PL (2); HU (2); BE (1); FR (2); RU (8); SE (1); IL (2)