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

NCT05192382 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 3 other identifiers: CRN00808-082021-001703-322024-511924-15-00
• Study Type: interventional
• Target: 111
• Locations: 15 countries
• Sites: 57

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.

Conditions

Acromegaly

Keywords

Acromegaly; PATHFNDR; Paltusotine; CRN00808

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Biochemical Response in Insulin-like Growth Factor-1 (IGF-1) 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.

  Week 24

Secondary Outcomes (4)

• 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

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 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Crinetics Pharmaceuticals Inc.: lead

Study Sites (57)

Crinetics Study Site

Aurora, Colorado, 80045, United States

Location

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Boston, Massachusetts, 02114, United States

Location

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Columbus, Ohio, 43210, United States

Location

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Portland, Oregon, 97239, United States

Location

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Philadelphia, Pennsylvania, 19104, United States

Location

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Pittsburgh, Pennsylvania, 15213, United States

Location

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CABA, Buenos Aires, C1012AAR, Argentina

Location

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Buenos Aires, C1405BCH, Argentina

Location

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CABA, 1425, Argentina

Location

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CABA, C1199ABB, Argentina

Location

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Córdoba, X5000, Argentina

Location

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Fortaleza, Ceará, 60430-275, Brazil

Location

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Belo Horizonte, Minas Gerais, 30130100, Brazil

Location

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Curitiba, Paraná, 80030-110, Brazil

Location

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Botucatu, São Paulo, 18618-686, Brazil

Location

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Campinas, São Paulo, 13060-904, Brazil

Location

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Rio de Janeiro, 20231-092, Brazil

Location

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São Paulo, 05403-000, Brazil

Location

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São Paulo, 1228000, Brazil

Location

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Sofia, 1431, Bulgaria

Location

Crinetics Study Site (b)

Beijing, Beijing Municipality, 100730, China

Location

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Guangzhou, Guangdong, 510080, China

Location

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Shijiazhuang, Hebei, 050000, China

Location

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Zhengzhou, Henan, 450000, China

Location

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Wuhan, Hubei, 430030, China

Location

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Changsha, Hunan, 410003, China

Location

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Jinan, Shandong, 250063, China

Location

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Xi’an, Shanxi, 710032, China

Location

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Chengdu, Sichuan, 610041, China

Location

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Hangzhou, Zhejiang, 310009, China

Location

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Marseille, 13395, France

Location

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Pessac, 33604, France

Location

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Toulouse, 31400, France

Location

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Aachen, 52074, Germany

Location

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Berlin, 10117, Germany

Location

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München, 80336, Germany

Location

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München, 81667, Germany

Location

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Würzburg, 97080, Germany

Location

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Athens, 10676, Greece

Location

Crinetics Study Site (b)

Athens, 11527, Greece

Location

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Thessaloniki, 54642, Greece

Location

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Budapest, 1062, Hungary

Location

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Budapest, 1083, Hungary

Location

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Pécs, 7624, Hungary

Location

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Bangalore, Karnataka, 560054, India

Location

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Belagavi, Karnataka, 590010, India

Location

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Kochi, Kerala, 682041, India

Location

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Mumbai, Maharashtra, 400012, India

Location

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Chandigarh, 160012, India

Location

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Delhi, 110029, India

Location

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Petah Tikva, 4941492, Israel

Location

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Roma, 00168, Italy

Location

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Bydgoszcz, 85-605, Poland

Location

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Poznan, 60-355, Poland

Location

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Wroclaw, 50-367, Poland

Location

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Barcelona, 08035, Spain

Location

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London, EC1M 6BQ, 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: January 5, 2022
• First Posted: January 14, 2022
• Study Start: December 17, 2021
• Primary Completion: January 20, 2024
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 23, 2026
• Results First Posted: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

HU (3); DE (5); ES (1); FR (3); GR (3); US (6); PL (3); IL (1); BU (1); IT (1); BR (8); GB (1); AR (5); IN (6); CN (10)