AcromegalyPhase 3PATHFNDR-2NCT05192382
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)
A Phase 3 study testing Paltusotine in people with Acromegaly, run by Crinetics Pharmaceuticals Inc. at 57 sites in 15 countries.
Trial summary
A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with non-pharmacologically treated acromegaly. 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
- 111 participants
- Where
- 57 sitesin 15 countries
- Study dates
- 17 Dec 2021to 2 Jun 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 either medically naïve, not currently treated, or willing to washout during the study screening period.
- 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
- Pituitary radiation therapy within 3 years of Screening
- Prior treatment with paltusotine
- History of ineffective or intolerance to octreotide or lanreotide
- 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 or previously using pegvisomant or cabergoline (within 16 weeks prior to Screening) or pasireotide LAR (within 24 weeks prior to Screening)
Trial locations and contacts
57 sites in 15 countries.
57 sites in 15 countries
China10 sites
Crinetics Study Site (b)
Beijing, Beijing Municipality, 100730
Crinetics Study Site
Changsha, Hunan, 410003
Crinetics Study Site
Chengdu, Sichuan, 610041
Crinetics Study Site
Guangzhou, Guangdong, 510080
Crinetics Study Site
Hangzhou, Zhejiang, 310009
Crinetics Study Site
Jinan, Shandong, 250063
Crinetics Study Site
Shijiazhuang, Hebei, 050000
Crinetics Study Site
Wuhan, Hubei, 430030
Crinetics Study Site
Xi’an, Shanxi, 710032
Crinetics Study Site
Zhengzhou, Henan, 450000
Brazil8 sites
Crinetics Study Site
Belo Horizonte, Minas Gerais, 30130100
Crinetics Study Site
Botucatu, São Paulo, 18618-686
Crinetics Study Site
Campinas, São Paulo, 13060-904
Crinetics Study Site
Curitiba, Paraná, 80030-110
Crinetics Study Site
Fortaleza, Ceará, 60430-275
Crinetics Study Site
Rio de Janeiro, 20231-092
Crinetics Study Site
São Paulo, 05403-000
Crinetics Study Site
São Paulo, 1228000
United States6 sites
Crinetics Study Site
Aurora, Colorado, 80045
Crinetics Study Site
Boston, Massachusetts, 02114
Crinetics Study Site
Columbus, Ohio, 43210
Crinetics Study Site
Philadelphia, Pennsylvania, 19104
Crinetics Study Site
Pittsburgh, Pennsylvania, 15213
Crinetics Study Site
Portland, Oregon, 97239
India6 sites
Crinetics Study Site
Bangalore, Karnataka, 560054
Crinetics Study Site
Belagavi, Karnataka, 590010
Crinetics Study Site
Chandigarh, 160012
Crinetics Study Site
Delhi, 110029
Crinetics Study Site
Kochi, Kerala, 682041
Crinetics Study Site
Mumbai, Maharashtra, 400012
Argentina5 sites
Crinetics Study Site
Buenos Aires, C1405BCH
Crinetics Study Site
CABA, Buenos Aires, C1012AAR
Crinetics Study Site
CABA, 1425
Crinetics Study Site
CABA, C1199ABB
Crinetics Study Site
Córdoba, X5000
Germany5 sites
Crinetics Study Site
Aachen, 52074
Crinetics Study Site
Berlin, 10117
Crinetics Study Site
München, 80336
Crinetics Study Site
München, 81667
Crinetics Study Site
Würzburg, 97080
France3 sites
Crinetics Study Site
Marseille, 13395
Crinetics Study Site
Pessac, 33604
Crinetics Study Site
Toulouse, 31400
Greece3 sites
Crinetics Study Site
Athens, 10676
Crinetics Study Site (b)
Athens, 11527
Crinetics Study Site
Thessaloniki, 54642
Hungary3 sites
Crinetics Study Site
Budapest, 1062
Crinetics Study Site
Budapest, 1083
Crinetics Study Site
Pécs, 7624
Poland3 sites
Crinetics Study Site
Bydgoszcz, 85-605
Crinetics Study Site
Poznan, 60-355
Crinetics Study Site
Wroclaw, 50-367
About this study
Official title: A Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Non-pharmacologically Treated Acromegaly (PATHFNDR-2)
A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with non-pharmacologically treated acromegaly.
- 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 With a Biochemical Response in Insulin-like Growth Factor-1 (IGF-1) 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.
Measured: Week 24
Secondary outcomes (4)
Change in IGF-1 From Baseline to EOT
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 24 weeks
Percentage of Participants Achieving IGF-1 <1.3×ULN at EOR
A value >1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Response is defined as an IGF-1 level <1.3×ULN based on the average of last 2 measurements.
Measured: 24 weeks
Percentage of Participants With Growth Hormone (GH) Concentration <1 ng/mL at Week 22
The average from integrated GH sampling at week 22 was used to determine response.
Measured: Week 22
Change From Baseline in Total Acromegaly Symptoms Diary (ASD) Score to EOT
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 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start17 Dec 2021
- Primary completion20 Jan 2024
- Study completion2 Jun 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
- 111 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
- NCT05192382
- Sponsor's protocol ID
- CRN00808-08
- Other IDs
- 2021-001703-32, 2024-511924-15-00
- Acronym
- PATHFNDR-2
- Status last verified
- Jun 2026
- First submitted
- 5 Jan 2022
- 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