AcromegalyPhase 2NCT03789656
An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)
A Phase 2 study testing Paltusotine in people with Acromegaly, run by Crinetics Pharmaceuticals Inc. at 26 sites in 12 countries.
Trial summary
An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens. 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
- 47 participants
- Where
- 26 sitesin 12 countries
- Study dates
- 12 Mar 2019to 31 Aug 2020
- 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
- Male and female subjects 18 to 75 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
Who cannot join
- 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
Show all 13Show 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, 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)
Trial locations and contacts
26 sites in 12 countries.
26 sites in 12 countries
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48106
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
UCLA Gonda Diabetes Center
Los Angeles, California, 90095
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, 15212
OHSU Northwest Pituitary Center
Portland, Oregon, 97239
Greece4 sites
General Hospital of Athens "Evangelismos"
Athens
General Hospital of Athens "Gennimatas"
Athens
General Hospital of Athens "Laiko"
Athens
General Hospital of Athens "Ippokratio"
Thessaloniki
Brazil3 sites
CETI - Centro de Estudos em Terapias Inovadoras
Curitiba
Hospital Universitário Clementino Fraga Filho (HUCFF/UFRJ) Centro de Pesquisa em Neuroendocrinologia
Rio de Janeiro
CPQuali Pesquisa Clinica
São Paulo
Hungary3 sites
Military Health Center, Division of Endocrinology
Budapest
Semmelweis University Faculty of Medicine
Budapest
University of Pécs Medical School
Pécs
New Zealand2 sites
Waitemata District Health Board, North Shore Hospital
Takapuna
Endocrine, Diabetes and Research Centre, Wellington Hospital
Wellington
United Kingdom2 sites
University Hospitals Coventry and Warwickshire NHS Trust
Coventry
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
Poland1 site
Clinic of Endocrinology Independent Public Health Care Centre University Hospital in Kracow
Krakow
Serbia1 site
Clinical Centre Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases
Belgrade
About this study
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)
An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.
- Conditions
- Acromegaly
- Being tested
- Paltusotine
- Keywords
- Acromegaly, ACROBAT, EDGE, 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, capsules, 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.
Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level
Change from baseline in IGF-1 level at Week 13/End of Treatment (W13/EoT) in Group 1 subjects Efficacy Analysis Set (EAS).
Measured: 13 Weeks
Secondary outcomes (2)
Proportion of Subjects With Their Last IGF-1 Measurement ≤ Upper Limit of Normal (ULN)
The secondary endpoint was the proportion of participants who maintained IGF-1 response, defined as the last assessment before the EoT with IGF-1 ≤1.0× ULN meet responder criteria, in Group 3, 4, and 5 subjects only at W13/EoT
Measured: 13 Weeks
Proportion of Subjects With Their Last IGF-1 Measurements ≤1.5×ULN
Proportion of participants with IGF-1 ≤1.5× ULN at W13/EoT.
Measured: 13 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start12 Mar 2019
- Primary completion3 Aug 2020
- Study completion31 Aug 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 47 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
- NCT03789656
- Sponsor's protocol ID
- CRN00808-03
- Other IDs
- 2018-002230-20, 2018
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2018
- Last updated
- 17 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martin S, Bender RH, Krasner A, Marmon T, Monahan M, Nelson L. Development and evaluation of the Acromegaly Symptom Diary. J Patient Rep Outcomes. 2023 Feb 15;7(1):15. doi: 10.1186/s41687-023-00541-7.
PubMed 36792844