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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03792555
Recruitment Status : Active, not recruiting
First Posted : January 3, 2019
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Crinetics Pharmaceuticals Inc.

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; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly that are responders to octreotide LAR or lanreotide depot.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: Paltusotine Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomized Withdrawal Study to Evaluate the Safety, Pharmacokinetics and Efficacy of CRN00808 in Patients With Acromegaly That Are Responders to Octreotide LAR or Lanreotide Depot (ACROBAT Evolve)
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Paltusotine Drug: Paltusotine
Paltusotine, capsules, once daily by mouth
Other Name: CRN00808

Placebo Comparator: Placebo Drug: Placebo
Placebo, capsules, once daily by mouth




Primary Outcome Measures :
  1. Proportion of subjects who meet responder criteria (based on the mean of two consecutive insulin-like growth factor-1 [IGF-1] measurements ≤ upper limit of normal [ULN]) [ Time Frame: 13 Weeks ]

Secondary Outcome Measures :
  1. Change in IGF-1 levels [ Time Frame: From Week 10 to Week 13 ]
  2. Change in growth hormone (GH) levels [ Time Frame: From Week 8 to Week 13 ]
  3. Change in patient assessed symptoms of acromegaly [ Time Frame: From Week 10 to Week 13 ]
    Total score computed by adding each of the individual acromegaly symptom intensities (headache pain, joint pain, sweating, fatigue, weakness in legs, swelling, numbness or tingling).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects 18 to 70 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792555


Locations
Show Show 45 study locations
Sponsors and Collaborators
Crinetics Pharmaceuticals Inc.

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Responsible Party: Crinetics Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03792555    
Other Study ID Numbers: CRN00808-02
2018-001833-42 ( EudraCT Number )
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Crinetics Pharmaceuticals Inc.:
Acromegaly
ACROBAT
EVOLVE
Paltusotine
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases