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NCT03792555·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

13

Locations

11

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Paltusotine

Paltusotine, capsules, once daily by mouth

DRUG

Placebo

Placebo, capsules, once daily by mouth

Timeline

From registration to results.

  1. First posted

    Jan 3, 2019

  2. Study start

    Mar 11, 2019

  3. Primary completion

    Jul 15, 2020

  4. Study completion

    Aug 12, 2020

  5. Results posted

    Mar 17, 2025

  6. Registry updated

    Mar 17, 2025

Outcomes

What the study measures.

Primary outcomes

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

Time frame · 13 Weeks

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

Secondary outcomes

Change in IGF-1 Levels

Time frame · From Week 10 to Week 13

Change in IGF-1 levels between RWP Baseline/Week 10 and Week 13

Change in Growth Hormone (GH) Levels

Time frame · From Week 8 to Week 13

Change in growth hormone levels between RWP Baseline/Week 8 and Week 13

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

Time frame · From Week 10 to Week 13

Measured by total Acromegaly symptom diary (ASD) score from W10-W13. ASD is a sponsor-developed daily diary to assess important acromegaly symptoms from the patient perspective. It covers 7 symptoms (headache pain, joint pain, sweating, fatigue, weakness in legs, swelling, and numbness or tingling). Patients rate the severity of each experience in the past 24 hours on an 11-point numeric scale that ranges from 0 (no symptom) to 10 (worst symptom). A weekly average ASD score is calculated for each item as the sum of the item responses for a specific item over the course of the study week divided by the number of days on which the item was completed. The weekly average ASD total score is calculated by computing the sum of the weekly average item scores for the 7 items (total range from 0 to 70), where higher score = higher symptom severity.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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)

Study locations

11 registered sites.

Brazil · Greece · Hungary · New Zealand · Poland · Serbia · Slovakia · United States. Showing up to 24 locations stored in the fast local snapshot.

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

Related trials

More studies on Octreotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.