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

NCT03792555 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CRN00808-022018-001833-42
• Study Type: interventional
• Target: 13
• Locations: 8 countries
• Sites: 11

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

Keywords

Acromegaly; ACROBAT; EVOLVE; Paltusotine

Outcome Measures

Primary Outcomes (1)

• Responder Criteria Was Based on the Mean of Two Consecutive Insulin-like Growth Factor-1 [IGF-1] Measurements ≤ULN at Week 13

  Proportion of subjects who meet responder criteria (based on the mean of two consecutive IGF-1 measurements ≤ upper limit of normal \[ULN\])

  13 Weeks

Secondary Outcomes (3)

• Change in IGF-1 Levels

  From Week 10 to Week 13

• Change in Growth Hormone (GH) Levels

  From Week 8 to Week 13

• Change in Total ASD Score Between RWP Baseline/Week 10 and Week 13

  From Week 10 to Week 13

Study Arms (2)

Paltusotine

EXPERIMENTAL

Drug: Paltusotine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Paltusotine DRUG

Paltusotine, capsules, once daily by mouth

Also known as: CRN00808

Paltusotine

Placebo DRUG

Placebo, capsules, once daily by mouth

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects 18 to 75 years of age
• Confirmed diagnosis of acromegaly that is controlled on stable doses of octreotide LAR or lanreotide depot
• 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 acromegaly subjects
• Prior treatment with paltusotine
• 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.
• 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
• 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
• 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, 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
• 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)
• Subjects taking octreotide LAR at a dose higher than 40 mg or lanreotide depot at a dose higher than 120 mg
• Subjects who usually take octreotide LAR or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)

Sponsors & Collaborators

• Crinetics Pharmaceuticals Inc.: lead

Study Sites (11)

Ohio State University

Columbus, Ohio, 43210, United States

Location

The Research Institute of Dallas

Dallas, Texas, 10260, United States

Location

CETI - Centro de Estudos em Terapias Inovadoras

Curitiba, Brazil

Location

CPQuali Pesquisa Clinica

São Paulo, Brazil

Location

General Hospital of Athens "Gennimatas"

Athens, Greece

Location

Semmelweis University Faculty of Medicine

Budapest, Hungary

Location

University of Pécs Medical School

Pécs, Hungary

Location

Endocrine, Diabetes and Research Centre, Wellington Hospital

Wellington, New Zealand

Location

The Centre of Postgraduate Medical Education

Warsaw, Poland

Location

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

Belgrade, Serbia

Location

National Institute of Endocrinology and Diabetology

Ľubochňa, Slovakia

Location

Related Publications (1)

• 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.

  PMID: 36792844 DERIVED

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

Limitations and Caveats

Due to small sample size, a number of exploratory endpoints were defined but not summarised. All primary and secondary endpoints are reported.

Results Point of Contact

• Title: Crinetics Clinical Trials
• Organization: Crinetics Pharmaceuticals Inc.

clinicaltrials@crinetics.com

+1 858-450-6464

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: January 3, 2019
• Study Start: March 11, 2019
• Primary Completion: July 15, 2020
• Study Completion: August 12, 2020
• Last Updated: March 17, 2025
• Results First Posted: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2); SE (1); GR (1); NZ (1); US (2); SL (1); HU (2); PL (1)