A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)

NCT ID: NCT03792555

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2020-08-12

Brief Summary

A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are responders to octreotide LAR or lanreotide depot.

Conditions

Acromegaly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Paltusotine

Group Type: EXPERIMENTAL

Paltusotine

Intervention Type: DRUG

Paltusotine, capsules, once daily by mouth

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, capsules, once daily by mouth

Interventions

Paltusotine

Paltusotine, capsules, once daily by mouth

Intervention Type: DRUG

Placebo

Placebo, capsules, once daily by mouth

Intervention Type: DRUG

Other Intervention Names

CRN00808

Eligibility Criteria

Inclusion Criteria

1. Male and female subjects 18 to 75 years of age

2. Confirmed diagnosis of acromegaly that is controlled on stable doses of octreotide LAR or lanreotide depot

3. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control

4. Willing to provide signed informed consent

Exclusion Criteria

1. Treatment naïve acromegaly subjects

2. Prior treatment with paltusotine

3. Pituitary surgery within 6 months prior to Screening or radiation therapy at any time prior to the study entry. Pituitary radiation therapy (within 3 to 4 years or more than 4 years prior to study entry) with recently documented elevated IGF-1 may be eligible.

4. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years.

5. Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer

6. 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

7. History of alcohol or substance abuse in the past 12 months

8. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study

9. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities.

10. Subjects with symptomatic cholelithiasis

11. 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

12. Subjects who have been taking the following prior medications: pegvisomant (within the last 3 months), dopamine agonists (within the last 3 months) and pasireotide LAR (within the last 6 months)

13. Subjects taking octreotide LAR at a dose higher than 40 mg or lanreotide depot at a dose higher than 120 mg

14. Subjects who usually take octreotide LAR or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Crinetics Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ohio State University

Columbus, Ohio, United States

The Research Institute of Dallas

Dallas, Texas, United States

CETI - Centro de Estudos em Terapias Inovadoras

Curitiba, , Brazil

CPQuali Pesquisa Clinica

São Paulo, , Brazil

General Hospital of Athens "Gennimatas"

Athens, , Greece

Semmelweis University Faculty of Medicine

Budapest, , Hungary

University of Pécs Medical School

Pécs, , Hungary

Endocrine, Diabetes and Research Centre, Wellington Hospital

Wellington, , New Zealand

The Centre of Postgraduate Medical Education

Warsaw, , Poland

Clinical Centre Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases

Belgrade, , Serbia

National Institute of Endocrinology and Diabetology

Ľubochňa, , Slovakia

Countries

United States; Brazil; Greece; Hungary; New Zealand; Poland; Serbia; Slovakia

References

Martin S, Bender RH, Krasner A, Marmon T, Monahan M, Nelson L. Development and evaluation of the Acromegaly Symptom Diary. J Patient Rep Outcomes. 2023 Feb 15;7(1):15. doi: 10.1186/s41687-023-00541-7.

Reference Type: DERIVED

PMID: 36792844 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-001833-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRN00808-02

Identifier Type: -

Identifier Source: org_study_id