NCT03792555

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Crinetics Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	Paltusotine	Paltusotine, capsules, once daily by mouth
DRUG	Placebo	Placebo, capsules, once daily by mouth

Timeline

• Start date: 2019-03-11
• Primary completion: 2020-07-15
• Completion: 2020-08-12
• First posted: 2019-01-03
• Last updated: 2025-03-17
• Results posted: 2025-03-17

Locations

11 sites across 8 countries: United States, Brazil, Greece, Hungary, New Zealand, Poland, Serbia, Slovakia

Regulatory

• FDA-regulated drug study