A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-1)
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ClinicalTrials.gov Identifier: NCT04837040 |
Recruitment Status :
Recruiting
First Posted : April 8, 2021
Last Update Posted : April 29, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acromegaly | Drug: Paltusotine Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 52 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Acromegaly Treated With Long-acting Somatostatin Receptor Ligands (PATHFNDR-1) |
Actual Study Start Date : | May 12, 2021 |
Estimated Primary Completion Date : | June 2023 |
Estimated Study Completion Date : | June 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: Paltusotine |
Drug: Paltusotine
Paltusotine, tablets, once daily by mouth
Other Name: CRN00808 |
Placebo Comparator: Placebo |
Drug: Placebo
Placebo, tablets, once daily by mouth |
- Proportion of subjects who maintain biochemical response in IGF-1 (≤1.0× the upper limit of normal [ULN]) at the End of the Randomized Control Phase (EOR) [ Time Frame: 36 Weeks ]
- Change from baseline in IGF-1 to EOR [ Time Frame: 36 Weeks ]
- Proportion of subjects with GH <1.0 ng/mL at Week 34, out of those who had GH <1.0 ng/mL at baseline [ Time Frame: 36 Weeks ]
- Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR [ Time Frame: 36 Weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female subjects ≥18 years of age
- Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 <ULN) via stable dose of protocol defined somatostatin receptor ligand therapy
- 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 24 weeks prior to Screening or history of pituitary radiation therapy
- 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
- Known history of HIV, hepatitis B, or active hepatitis C
- 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, or 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 currently taking pasireotide LAR (within 24 weeks prior to Screening) or pegvisomant, dopamine agonists, or short acting somatostatin analogs (with 12 weeks prior to Screening)

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): NCT04837040
Contact: Crinetics Clinical Trials | 833-827-9741 | clinicaltrials@crinetics.com |

Responsible Party: | Crinetics Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT04837040 |
Other Study ID Numbers: |
CRN00808-09 2020-005431-70 ( EudraCT Number ) |
First Posted: | April 8, 2021 Key Record Dates |
Last Update Posted: | April 29, 2022 |
Last Verified: | April 2022 |
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 PATHFNDR Paltusotine CRN00808 |
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 |