An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)

Phase 2 Completed 47 enrolled Crinetics Pharmaceuticals Inc.

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2019-03-12
Primary completion: 2020-08-03
Completion: 2020-08-31

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry analysis (other test); Group 1; p = 0.6285; Wilcoxon Signed Rank test reads as missed primary endpoint NCT03789656 ↗

release “The prespecified primary endpoint in Edge was achieved, showing that once daily oral paltusotine maintained insulin-like growth factor-1 (IGF-1) levels at Week 13 in acromegaly” reads as met primary endpoint crinetics.com ↗

release “The prespecified primary endpoint in Edge was achieved, showing that once – daily oral paltusotine maintained insulin-like growth factor-1 (IGF-1) levels at Week 13” reads as met primary endpoint crinetics.com ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paltusotine	Small molecule	—	Oral