Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT03792555Other idCRN00808-02Other id2018-001833-42Other id2018

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Measures Lanreotide, does not give it. It appears in the eligibility rules.
Measures Octreotide, does not give it. It appears in the eligibility rules.

Overview

Status: Completed
Phase: Phase 2
Enrollment: 13 participants (actual)
Sponsor: Crinetics Pharmaceuticals Inc. · Industry
Design: Randomized · Triple masking
Countries: 8 countries
United States, Brazil, Greece, Hungary, New Zealand, Poland, Serbia, Slovakia
Start: 11 Mar 2019
Primary completion: 15 Jul 2020
Completion: 12 Aug 2020
First posted: 3 Jan 2019
Last update posted: 17 Mar 2025
Conditions: Acromegaly

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201920202021

Ph 2
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)
NCT03792555
11 Mar 2019 to 12 Aug 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

PaltusotineDrug
PlaceboDrug

Arms2

Experimental
Paltusotine
Placebo comparator
Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
Proportion of subjects who meet responder criteria (based on the mean of two consecutive IGF-1 measurements ≤ upper limit of normal \[ULN\])

Secondary outcomes(3)

Change in IGF-1 Levels
Time frame · From Week 10 to Week 13
Registry description
Change in IGF-1 levels between RWP Baseline/Week 10 and Week 13
Change in Growth Hormone (GH) Levels
Time frame · From Week 8 to Week 13
Registry description
Change in growth hormone levels between RWP Baseline/Week 8 and Week 13
Change in Total ASD Score Between RWP Baseline/Week 10 and Week 13
Time frame · From Week 10 to Week 13
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 13 Weeks

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

Group	Value (percentage of responders)
Randomized Withdrawal Period: Paltusotine	66.7
Randomized Withdrawal Period: Placebo	25.0
Randomized Withdrawal Period: Not Randomized	16.7

Secondary and other outcome results(3)

Secondary outcomeMean· From Week 10 to Week 13

Change in IGF-1 Levels

Group	Value (percent change in IGF1)	Spread
Randomized Withdrawal Period: Paltusotine	4.04	5.064
Randomized Withdrawal Period: Placebo	48.17	41.408
Randomized Withdrawal Period: Not Randomized	not posted	–

Secondary outcomeMean· From Week 8 to Week 13

Change in Growth Hormone (GH) Levels

Group	Value (percent change in GH)	Spread
Randomized Withdrawal Period: Paltusotine	71.96	48.865
Randomized Withdrawal Period: Placebo	108.30	179.977
Randomized Withdrawal Period: Not Randomized	not posted	–

Secondary outcomeMean· From Week 10 to Week 13

Change in Total ASD Score Between RWP Baseline/Week 10 and Week 13

Group	Value (Total ASD score change -units on a scale)	Spread
Randomized Withdrawal Period: Paltusotine	1.571	3.1004
Randomized Withdrawal Period: Placebo	7.962	7.1591
Randomized Withdrawal Period: Not Randomized	not posted	–

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Safety Analysis Set/Titration Period - PaltusotineAll participants who received a dose of Paltusotine during the titration period.	0 / 13	0 / 13	8 / 13
Randomized Withdrawal Period - PaltusotineAdverse events reported during the randomised withdrawal period by those receiving Paltusotine treatment	0 / 3	0 / 3	3 / 3
Randomized Withdrawal Period - PlaceboAdverse events reported during the randomised withdrawal period by those receiving Placebo	0 / 4	0 / 4	4 / 4
Total PaltusotineAll participants who received a dose of paltusotine. Includes all participants randomized into the RWP, and those not randomized that were allowed to stay in the study and continue dosing at a study drug dose that was tolerated, until the participant completed all study visits.	0 / 13	0 / 13	10 / 13

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedMartin 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. PMID 36792844

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Male and female subjects 18 to 75 years of age 2. Confirmed diagnosis of acromegaly that is controlled on stable doses of octreotide LAR or lanreotide depot 3. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control 4. Willing to provide signed informed consent Exclusion Criteria: 1. Treatment naïve acromegaly subjects 2. Prior treatment with paltusotine 3. 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. 4. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years. 5. Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer 6. 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 7. History of alcohol or substance abuse in the past 12 months 8. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study 9. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities. 10. Subjects with symptomatic cholelithiasis 11. 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 12. 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) 13. Subjects taking octreotide LAR at a dose higher than 40 mg or lanreotide depot at a dose higher than 120 mg 14. Subjects who usually take octreotide LAR or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)

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