AcromegalyPhase 3PATHFNDR-1NCT04837040
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly
A Phase 3 study testing Paltusotine in people with Acromegaly, run by Crinetics Pharmaceuticals Inc. at 39 sites in 14 countries.
Trial summary
A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Paltusotine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 39 sitesin 14 countries
- Study dates
- 12 May 2021to 29 May 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects ≥18 years of age
- Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 ≤1.0×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
Who cannot join
- Treatment naïve or treatment-withdrawn acromegaly subjects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
Show all 12Show fewer
- 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 (within 12 weeks prior to Screening), or short acting somatostatin analogs (within 12 weeks prior to first dose of study drug)
Trial locations and contacts
39 sites in 14 countries.
39 sites in 14 countries
Russia8 sites
Crinetics Study Site
Kazan', Tatarstan Republic, 420097
Crinetics Study Site
Kemerovo, Kemerovo Oblast, 650066
Crinetics Study Site
Moscow, 117186
Crinetics Study Site
Moscow, 119435
Crinetics Study Site
Moscow, 125008
Crinetics Study Site
Novosibirsk, Novosibirsk Oblast, 630005
Crinetics Study Site
Novosibirsk, Novosibirsk Oblast, 630087
Crinetics Study Site
Samara, Samara Oblast, 443041
United States7 sites
Crinetics Study Site
Baltimore, Maryland, 21205
Crinetics Study Site
Boston, Massachusetts, 02114
Crinetics Study Site
Los Angeles, California, 90048
Crinetics Study Site
Nashville, Tennessee, 37203
Crinetics Study Site
Philadelphia, Pennsylvania, 19104
Crinetics Study Site
Pittsburgh, Pennsylvania, 15212
Crinetics Study Site
Torrance, California, 90502
Brazil5 sites
Crinetics Study Site
Curitiba, Paraná, 80030-110
Crinetics Study Site
Fortaleza, Ceará, 60430-275
Crinetics Study Site
Porto Alegre, Rio Grande do Sul, 90410-000
Crinetics Study Site
Rio de Janeiro, 20231-092
Crinetics Study Site
Rio de Janeiro, 21941-913
Argentina3 sites
Crinetics Study Site
CABA, Buenos Aires, C1012AAR
Crinetics Study Site
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1405BCH
Crinetics Study Site
Córdoba, X5000
United Kingdom3 sites
Crinetics Study Site
Coventry, West Midlands, CV2 2DX
Crinetics Study Site
London, W12 0HS
Crinetics Study Site
Sheffield, South Yorkshire, S102JF
France2 sites
Crinetics Study Site
Bron, 69677
Crinetics Study Site
Pessac, 33604
Hungary2 sites
Crinetics Study Site
Budapest, 1083
Crinetics Study Site
Pécs, 7624
Israel2 sites
Crinetics Study Site
Beersheba, 8410101
Crinetics Study Site
Petah Tikva, 4941480
Poland2 sites
Crinetics Study Site
Bydgoszcz, 85-605
Crinetics Study Site
Poznan, 60-355
About this study
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)
A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.
- Conditions
- Acromegaly
- Being tested
- Paltusotine, Placebo
- Keywords
- Acromegaly, PATHFNDR, Paltusotine, CRN00808
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaltusotineDrug
Also called CRN00808
Paltusotine, tablets, once daily by mouth
PlaceboDrug
Placebo, tablets, once daily by mouth
| Study group | Role | What they receive |
|---|---|---|
| Paltusotine | Experimental | Not described Receives: Drug: Paltusotine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Maintain Biochemical Response in IGF-1 (≤1.0× the Upper Limit of Normal [ULN]) at the End of the Randomized Control Phase (EOR)
A value >1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Response is defined as an IGF-1 level ≤1.0×ULN based on the average of last 2 measurements (weeks 34 and 36).
Measured: 36 Weeks
Secondary outcomes (3)
Change From Baseline in IGF-1 to EOR
A value >1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Baseline was defined as the last non-missing assessment prior to first dose of study drug for all assessments except IGF-1, growth hormone (GH), and acromegaly symptoms diary (ASD). Change from Baseline was determined by calculating (post-Baseline value - Baseline value).
Measured: Baseline to 36 Weeks
Percentage of Participants With GH <1.0 ng/mL at Week 34
GH maintenance of response was analyzed in participants with GH<1.0 ng/mL at week 34, out of those who had GH<1.0 ng/mL at Baseline, using the same methodology as the primary endpoint.
Measured: Week 34
Change From Baseline in Total Acromegaly Symptoms Diary (ASD) Score to EOR
The ASD is a sponsor-developed daily diary to assess important acromegaly symptoms from the patient perspective. The weekly average ASD total score is calculated from 7 items associated with acromegaly (headache pain, joint pain, sweating, fatigue, weakness in legs, swelling, and numbness or tingling). The ASD total score ranges from 0 to 70 with each symptom contributing up to 10 points. A higher score = higher symptom severity. Change from baseline in total ASD was defined as the postbaseline total ASD score (the average of the available scores seven days on or prior to the scheduled visit date) minus the baseline total ASD score.
Measured: Baseline to 36 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start12 May 2021
- Primary completion10 Jul 2023
- Study completion29 May 2026
Why it stopped: The study was stopped early for business reasons (not due to changes in the benefits or risks of paltusotine).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crinetics Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837040
- Sponsor's protocol ID
- CRN00808-09
- Other IDs
- 2020-005431-70, 2024-511925-71-00
- Acronym
- PATHFNDR-1
- Status last verified
- Jun 2026
- First submitted
- 6 Apr 2021
- Last updated
- 15 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No