AcromegalyPhase 2NCT03792555

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)

A Phase 2 study testing Paltusotine in people with Acromegaly, run by Crinetics Pharmaceuticals Inc. at 11 sites in 8 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

A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are responders to octreotide LAR or lanreotide depot. 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?: Yes, some participants may receive a placebo
How many people: 13 participants
Where: 11 sitesin 8 countries
Study dates: 11 Mar 2019to 12 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 that is controlled on stable doses of octreotide LAR or lanreotide depot
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 or radiation therapy at any time prior to the study entry. Pituitary radiation therapy (within 3 to 4 years or more than 4 years prior to study entry) with recently documented elevated IGF-1 may be eligible.
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 14Show 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 who have been taking the following prior medications: pegvisomant (within the last 3 months), dopamine agonists (within the last 3 months) and pasireotide LAR (within the last 6 months)
Subjects taking octreotide LAR at a dose higher than 40 mg or lanreotide depot at a dose higher than 120 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

11 sites in 8 countries.

Country

City, postcode or hospital

11 sites in 8 countries

United States2 sites

Ohio State University
Columbus, Ohio, 43210
The Research Institute of Dallas
Dallas, Texas, 10260

Other trials in United States

Brazil2 sites

CETI - Centro de Estudos em Terapias Inovadoras
Curitiba
CPQuali Pesquisa Clinica
São Paulo

Other trials in Brazil

Hungary2 sites

Semmelweis University Faculty of Medicine
Budapest
University of Pécs Medical School
Pécs

Other trials in Hungary

Greece1 site

General Hospital of Athens "Gennimatas"
Athens

Other trials in Greece

New Zealand1 site

Endocrine, Diabetes and Research Centre, Wellington Hospital
Wellington

Other trials in New Zealand

Poland1 site

The Centre of Postgraduate Medical Education
Warsaw

Other trials in Poland

Serbia1 site

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

Other trials in Serbia

Slovakia1 site

National Institute of Endocrinology and Diabetology
Ľubochňa

Other trials in Slovakia

About this study

Official title: A Double-blind, Placebo-controlled, Randomized Withdrawal Study to Evaluate the Safety, Pharmacokinetics and Efficacy of CRN00808 in Patients With Acromegaly That Are Responders to Octreotide LAR or Lanreotide Depot (ACROBAT Evolve)

Conditions: Acromegaly
Being tested: Paltusotine, Placebo
Keywords: Acromegaly, ACROBAT, EVOLVE, 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
PlaceboDrug
Placebo, capsules, once daily by mouth

Study groups in NCT03792555
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.

Responder Criteria Was Based on the Mean of Two Consecutive Insulin-like Growth Factor-1 [IGF-1] Measurements ≤ULN at Week 13
Proportion of subjects who meet responder criteria (based on the mean of two consecutive IGF-1 measurements ≤ upper limit of normal [ULN])
Measured: 13 Weeks

Secondary outcomes (3)

Change in IGF-1 Levels
Change in IGF-1 levels between RWP Baseline/Week 10 and Week 13
Measured: From Week 10 to Week 13
Change in Growth Hormone (GH) Levels
Change in growth hormone levels between RWP Baseline/Week 8 and Week 13
Measured: From Week 8 to Week 13
Change in Total ASD Score Between RWP Baseline/Week 10 and Week 13
Measured by total Acromegaly symptom diary (ASD) score from W10-W13.
ASD is a sponsor-developed daily diary to assess important acromegaly symptoms from the patient perspective. It covers 7 symptoms (headache pain, joint pain, sweating, fatigue, weakness in legs, swelling, and numbness or tingling). Patients rate the severity of each experience in the past 24 hours on an 11-point numeric scale that ranges from 0 (no symptom) to 10 (worst symptom).
A weekly average ASD score is calculated for each item as the sum of the item responses for a specific item over the course of the study week divided by the number of days on which the item was completed.
The weekly average ASD total score is calculated by computing the sum of the weekly average item scores for the 7 items (total range from 0 to 70), where higher score = higher symptom severity.
Measured: From Week 10 to Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Mar 201912 Aug 2020

First posted3 Jan 2019
Study start11 Mar 2019
Primary completion15 Jul 2020
Study completion12 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03792555
Sponsor's protocol ID: CRN00808-02
Other IDs: 2018-001833-42, 2018
Status last verified: Mar 2025
First submitted: 27 Dec 2018
Last updated: 17 Mar 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 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo-controlled, Randomized Withdrawal Study to Evaluate the Safety, Pharmacokinetics and Efficacy of CRN00808 in Patients With Acromegaly That Are Responders to Octreotide LAR or Lanreotide Depot (ACROBAT Evolve)
ClinicalTrials.gov ID: NCT03792555
Acronym / sponsor ID: CRN00808-02
Conditions: Acromegaly
Keywords: Acromegaly, ACROBAT, EVOLVE, Paltusotine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Crinetics Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: 11 Mar 2019 (actual)
Primary completion: 15 Jul 2020 (actual)
Study completion: 12 Aug 2020 (actual)
First posted: 3 Jan 2019 (actual)
Results: Posted 17 Mar 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Paltusotine	Experimental	Drug: Paltusotine
Placebo	Placebo comparator	Drug: Placebo

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 that is controlled on stable doses of octreotide LAR or lanreotide depot
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 (14 listed)

Treatment naïve acromegaly subjects
Prior treatment with paltusotine
Pituitary surgery within 6 months prior to Screening or radiation therapy at any time prior to the study entry. Pituitary radiation therapy (within 3 to 4 years or more than 4 years prior to study entry) with recently documented elevated IGF-1 may be eligible.
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
PlaceboPlacebo, capsules, once daily by mouth	Drug	Placebo

Primary outcome

Responder Criteria Was Based on the Mean of Two Consecutive Insulin-like Growth Factor-1 [IGF-1] Measurements ≤ULN at Week 13
Time frame: 13 Weeks
Proportion of subjects who meet responder criteria (based on the mean of two consecutive IGF-1 measurements ≤ upper limit of normal [ULN])

3 secondary outcomes

Change in IGF-1 Levels
Time frame: From Week 10 to Week 13
Change in Growth Hormone (GH) Levels
Time frame: From Week 8 to Week 13
Change in Total ASD Score Between RWP Baseline/Week 10 and Week 13
Time frame: From Week 10 to Week 13

Results and safety

Results posted to the registry on 17 Mar 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
Titration Period: Paltusotine, Then Randomized Withdrawal Period: Paltusotine	3	3
Titration Period: Paltusotine, Then Randomized Withdrawal Period: Placebo	4	4
Titration Period: Paltusotine, Then Not Randomized	6	6

Primary outcome: Responder Criteria Was Based on the Mean of Two Consecutive Insulin-like Growth Factor-1 [IGF-1] Measurements ≤ULN at Week 13

Time frame: 13 Weeks. Number (95% Confidence Interval). Unit: percentage of responders

Measure	Randomized Withdrawal Period: Paltusotine n = 3	Randomized Withdrawal Period: Placebo n = 4	Randomized Withdrawal Period: Not Randomized n = 6
Value	66.7 (9.4 to 99.2)	25.0 (0.6 to 80.6)	16.7 (0.4 to 64.1)

Population analysed: The Analysis Population includes all subjects who received treatment in the titration period. This includes subjects who were randomized in the randomized withdrawal period to receive placebo or continue receiving paltusotine and subjects who were not randomized and continued receiving paltusotine. The primary endpoint of the proportion of subjects who met responder criteria (based on the mean of two consecutive IGF-1 measurements ≤ULN) at Week 13 is presented for all subjects.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Duration of participation for each subject after obtaining a signed informed consent was up to 23 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety Analysis Set/Titration Period - Paltusotine	0 of 13 (0%)	8 of 13 (61.5%)	0 of 13
Randomized Withdrawal Period - Paltusotine	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Randomized Withdrawal Period - Placebo	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Total Paltusotine	0 of 13 (0%)	10 of 13 (76.9%)	0 of 13

Limitations and caveats (from the sponsor): Due to small sample size, a number of exploratory endpoints were defined but not summarised. All primary and secondary endpoints are reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 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.

11 sites in 8 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 11 sites in 8 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 14 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 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Brazil, Hungary, Greece, New Zealand and 3 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. Some participants in this study may receive a placebo. 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 Mar 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?

Responder Criteria Was Based on the Mean of Two Consecutive Insulin-like Growth Factor-1 [IGF-1] Measurements ≤ULN at Week 13 (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 NCT03792555, 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 Mar 2025.