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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.

Country

City, postcode or hospital

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

Other trials in United States

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

Other trials in Greece

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

Other trials in Brazil

Hungary3 sites

Military Health Center, Division of Endocrinology
Budapest
Semmelweis University Faculty of Medicine
Budapest
University of Pécs Medical School
Pécs

Other trials in Hungary

New Zealand2 sites

Waitemata District Health Board, North Shore Hospital
Takapuna
Endocrine, Diabetes and Research Centre, Wellington Hospital
Wellington

Other trials in New Zealand

United Kingdom2 sites

University Hospitals Coventry and Warwickshire NHS Trust
Coventry
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF

Other trials in United Kingdom

Germany1 site

LMU Clinic of University of Munich
Munich

Other trials in Germany

Italy1 site

Azienda Ospedaliera Universitaria Federico II
Naples

Other trials in Italy

Poland1 site

Clinic of Endocrinology Independent Public Health Care Centre University Hospital in Kracow
Krakow

Other trials in Poland

Romania1 site

National Institute of Endocrinology "C. I. Parhon"
Bucharest

Other trials in Romania

Serbia1 site

Clinical Centre Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases
Belgrade

Other trials in Serbia

Slovakia1 site

University Hospital Bratislava
Bratislava

Other trials in Slovakia

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)

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 groups in NCT03789656
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.

12 Mar 201931 Aug 2020

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia

All Acromegaly trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03789656
Acronym / sponsor ID: CRN00808-03
Conditions: Acromegaly
Keywords: Acromegaly, ACROBAT, EDGE, Paltusotine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Crinetics Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: 12 Mar 2019 (actual)
Primary completion: 3 Aug 2020 (actual)
Study completion: 31 Aug 2020 (actual)
First posted: 28 Dec 2018 (actual)
Results: Posted 17 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Paltusotine	Experimental	Drug: Paltusotine

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PaltusotineAlso: CRN00808Paltusotine, capsules, once daily by mouth	Drug	Paltusotine

Primary outcome

Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level
Time frame: 13 Weeks
Change from baseline in IGF-1 level at Week 13/End of Treatment (W13/EoT) in Group 1 subjects Efficacy Analysis Set (EAS).

2 secondary outcomes

Proportion of Subjects With Their Last IGF-1 Measurement ≤ Upper Limit of Normal (ULN)
Time frame: 13 Weeks
Proportion of Subjects With Their Last IGF-1 Measurements ≤1.5×ULN
Time frame: 13 Weeks

Results and safety

Results posted to the registry on 17 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	25	25
Group 2	10	10
Group 3	5	5
Group 4	4	4
Group 5	3	3

Primary outcome: Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level

Time frame: 13 Weeks. Median (Inter-Quartile Range). Unit: ng/mL x ULN

Measure	Group 1 n = 25
Value	-0.034 (-0.107 to 1.07)

Group 1: p = 0.6285, Wilcoxon Signed Rank test

Population analysed: Efficacy Analysis Set includes all subjects in Group 1 who received at least one dose of study drug.

Primary outcome: Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level

Time frame: 13 Weeks. Median (Inter-Quartile Range). Unit: ng/mL x ULN

Measure	Group 1 n = 25
Baseline	1.335 (1.078 to 1.471)
Week 13 (Visit 14)/ End of Treatment	1.343 (1.169 to 1.448)

Population analysed: Efficacy Analysis Set includes all subjects in Group 1 who received at least one dose of study drug.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were monitored until the end of the 4-week follow-up period (up to 17 weeks total).. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose 5 mg	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Dose 10 mg	0 of 47 (0%)	23 of 47 (48.9%)	0 of 47
Dose 20 mg	1 of 43 (2.3%)	24 of 43 (55.8%)	0 of 43
Dose 30 mg	0 of 37 (0%)	15 of 37 (40.5%)	0 of 37
Dose 40 mg	0 of 32 (0%)	19 of 32 (59.4%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36792844Martin 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.
Individual participant dataSharing planned: No

Related trials for Acromegaly

RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

26 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paltusotine in people with Acromegaly, run by Crinetics Pharmaceuticals Inc. at 26 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Greece, Brazil, Hungary, New Zealand and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level (time frame: 13 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03789656, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.