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

NCT03792555 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-03-17

Study results available
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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

Interventions

DRUG

Paltusotine

Paltusotine, capsules, once daily by mouth

DRUG

Placebo

Placebo, capsules, once daily by mouth

Sponsors & Collaborators

  • Crinetics Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-11
Primary Completion
2020-07-15
Completion
2020-08-12
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Greece
  • Hungary
  • New Zealand
  • Poland
  • Serbia
  • Slovakia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03792555 on ClinicalTrials.gov