AcromegalyPhase 2NCT04261712
A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)
A Phase 2 study testing Paltusotine in people with Acromegaly, run by Crinetics Pharmaceuticals Inc. at 22 sites in 7 countries.
Trial summary
A phase 2, open label, long-term extension 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 acromegaly. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acromegaly
- What is being tested?
- Paltusotine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 22 sitesin 7 countries
- Study dates
- 29 Jan 2020to 30 Jun 2026
- Phase
- Phase 2
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed one of the parent studies (Acrobat Evolve [CRN00808-02] or Acrobat Edge [CRN00808-03])
- 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
- Clinically significant concomitant disease including, but not limited to, cardiovascular disease; moderate or severe renal insufficiency; or significant liver disease (including cirrhosis)
- Pituitary radiation since completing participation in parent studies
- History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
- Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab).
- History of alcohol or substance abuse in the past 12 months
- Use of any investigational drug (other than paltusotine) within the past 30 days or 5 half-lives, whichever is longer before Screening
Show all 10Show fewer
- 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
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
United States7 sites
Crinetics Study Site
Boston, Massachusetts, 02114
Crinetics Study Site
Chicago, Illinois, 60611
Crinetics Study Site
Columbus, Ohio, 43210
Crinetics Study Site
Dallas, Texas, 75231
Crinetics Study Site
Los Angeles, California, 90095
Crinetics Study Site
Pittsburgh, Pennsylvania, 15212
Crinetics Study Site
Pittsburgh, Pennsylvania, 15213
Brazil4 sites
Crinetics Study Site
Curitiba, Paraná, 80030-110
Crinetics Study Site
Rio de Janeiro, 20231
Crinetics Study Site
Rio de Janeiro, 21941
Crinetics Study Site
São Paulo, 01228
Greece4 sites
Crinetics Study Site
Athens, 10676
Crinetics Study Site 1
Athens, 11527
Crinetics Study Site 2
Athens, 11527
Crinetics Study Site
Thessaloniki, 54642
Hungary3 sites
Crinetics Study Site
Budapest, 1062
Crinetics Study Site
Budapest, 1083
Crinetics Study Site
Pécs, 7624
United Kingdom2 sites
Crinetics Study Site
Coventry
Crinetics Study Site
Leeds, LS97TF
About this study
Official title: An Open Label, Long-term Extension Study to Evaluate the Safety and Efficacy of CRN00808 in Subjects With Acromegaly (ACROBAT Advance)
A phase 2, open label, long-term extension 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 acromegaly.
- Conditions
- Acromegaly
- Being tested
- Paltusotine
- Keywords
- Acromegaly, ACROBAT, ADVANCE, Paltusotine
- 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, once daily by mouth
| Study group | Role | What they receive |
|---|---|---|
| Paltusotine | Experimental | Not described Receives: Drug: Paltusotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs) throughout the study
Measured: Week 316
Secondary outcomes (2)
Change in insulin-like growth factor-1 (IGF-1) level
Measured: Week 16, Week 312
Change in growth hormone (GH) level
Measured: Week 16, Week 312
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start29 Jan 2020
- Primary completion30 Jun 2026
- Study completion30 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 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
- NCT04261712
- Sponsor's protocol ID
- CRN00808-05
- Other IDs
- U1111-1245-5276, 2019-002193-31, 2024-511921-75-00, 2019
- Status last verified
- Jul 2026
- First submitted
- 6 Feb 2020
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No