NCT04261712

Brief Summary

A phase 2, open label, long-term extension 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 acromegaly.

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
22mo left

Started Jan 2020

Longer than P75 for phase_2

Geographic Reach
7 countries

22 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jan 2020Mar 2028

Study Start

First participant enrolled

January 29, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 22, 2026

Status Verified

December 1, 2025

Enrollment Period

8.1 years

First QC Date

February 6, 2020

Last Update Submit

April 21, 2026

Conditions

Acromegaly

Keywords

AcromegalyACROBATADVANCEPaltusotine

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment-emergent adverse events (TEAEs) throughout the study

    Week 316

Secondary Outcomes (2)

  • Change in insulin-like growth factor-1 (IGF-1) level

    Week 16, Week 312

  • Change in growth hormone (GH) level

    Week 16, Week 312

Study Arms (1)

Paltusotine

EXPERIMENTAL
Drug: Paltusotine

Interventions

PaltusotineDRUG

Paltusotine, once daily by mouth

Also known as: CRN00808
Paltusotine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completed one of the parent studies (Acrobat Evolve \[CRN00808-02\] or Acrobat Edge \[CRN00808-03\])
  • 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:

  • Clinically significant concomitant disease including, but not limited to, cardiovascular disease; moderate or severe renal insufficiency; or significant liver disease (including cirrhosis)
  • Pituitary radiation since completing participation in parent studies
  • History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
  • Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab).
  • History of alcohol or substance abuse in the past 12 months
  • Use of any investigational drug (other than paltusotine) within the past 30 days or 5 half-lives, whichever is longer before Screening
  • 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, and 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Crinetics Study Site

Los Angeles, California, 90095, United States

Location

Crinetics Study Site

Chicago, Illinois, 60611, United States

Location

Crinetics Study Site

Boston, Massachusetts, 02114, United States

Location

Crinetics Study Site

Columbus, Ohio, 43210, United States

Location

Crinetics Study Site

Pittsburgh, Pennsylvania, 15212, United States

Location

Crinetics Study Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Crinetics Study Site

Dallas, Texas, 75231, United States

Location

Crinetics Study Site

Curitiba, Paraná, 80030-110, Brazil

Location

Crinetics Study Site

Rio de Janeiro, 20231, Brazil

Location

Crinetics Study Site

Rio de Janeiro, 21941, Brazil

Location

Crinetics Study Site

São Paulo, 01228, Brazil

Location

Crinetics Study Site

München, 80336, Germany

Location

Crinetics Study Site

Athens, 10676, Greece

Location

Crinetics Study Site 1

Athens, 11527, Greece

Location

Crinetics Study Site 2

Athens, 11527, Greece

Location

Crinetics Study Site

Thessaloniki, 54642, Greece

Location

Crinetics Study Site

Budapest, 1062, Hungary

Location

Crinetics Study Site

Budapest, 1083, Hungary

Location

Crinetics Study Site

Pécs, 7624, Hungary

Location

Crinetics Study Site

Belgrade, 11000, Serbia

Location

Crinetics Study Site

Coventry, United Kingdom

Location

Crinetics Study Site

Leeds, LS97TF, United Kingdom

Location

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 10, 2020

Study Start

January 29, 2020

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

April 22, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(4)HU(3)SE(1)US(7)GB(2)GR(4)DE(1)