An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)
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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: NCT03789656 |
Recruitment Status :
Completed
First Posted : December 28, 2018
Last Update Posted : July 29, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acromegaly | Drug: Paltusotine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 47 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Label Exploratory Study to Evaluate the Safety, Pharmacokinetics and Efficacy of CRN00808 in Patients With Acromegaly Treated With Somatostatin Analogue Based Treatment Regimens (ACROBAT Edge) |
Actual Study Start Date : | January 15, 2019 |
Actual Primary Completion Date : | August 3, 2020 |
Actual Study Completion Date : | August 31, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Paltusotine |
Drug: Paltusotine
Paltusotine, capsules, once daily by mouth
Other Name: CRN00808 |
- Change from baseline (mean of Screening values) in insulin-like growth factor-1 (IGF-1) level [ Time Frame: 13 Weeks ]
- Proportion of subjects with their last IGF-1 measurement ≤ upper limit of normal (ULN) [ Time Frame: 13 Weeks ]
- Proportion of subjects with their last IGF-1 measurements ≤1.5×ULN [ Time Frame: 13 Weeks ]

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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 |
Inclusion Criteria:
- Male and female subjects 18 to 70 years of age
- Confirmed diagnosis of acromegaly with either a partial or complete response to protocol defined somatostatin analogue therapy regimens
- 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
Exclusion Criteria:
- Treatment naïve acromegaly subjects
- Prior treatment with paltusotine
- Pituitary surgery within 6 months prior to Screening. Subjects receiving radiation therapy may be eligible with some restrictions.
- 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 taking octreotide LAR at a dose higher than 40 mg, or lanreotide depot at a dose higher than 120 mg, or pasireotide LAR at a dose higher than 60 mg
- Subjects who usually take octreotide LAR or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)

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): NCT03789656

Responsible Party: | Crinetics Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT03789656 |
Other Study ID Numbers: |
CRN00808-03 2018-002230-20 ( EudraCT Number ) |
First Posted: | December 28, 2018 Key Record Dates |
Last Update Posted: | July 29, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Acromegaly ACROBAT EDGE Paltusotine |
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 |