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.
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
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.
11 sites in 8 countries
United States2 sites
Ohio State University
Columbus, Ohio, 43210
The Research Institute of Dallas
Dallas, Texas, 10260
Brazil2 sites
CETI - Centro de Estudos em Terapias Inovadoras
Curitiba
CPQuali Pesquisa Clinica
São Paulo
Hungary2 sites
Semmelweis University Faculty of Medicine
Budapest
University of Pécs Medical School
Pécs
New Zealand1 site
Endocrine, Diabetes and Research Centre, Wellington Hospital
Wellington
Serbia1 site
Clinical Centre Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases
Belgrade
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)
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Crinetics Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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