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Study to Assess an Enteric Microgranule Formulation of Adrulipase in Patients With Cystic Fibrosis

NCT05719311 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-09-19

Study results available
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Summary

Some cystic fibrosis patients are unable to digest food and absorb nutrition appropriately as they have a condition known as exocrine pancreatic insufficiency (EPI). Currently, these patients take pancreatic enzymes that are obtained from pig pancreas to aid the digestion of food. The goals of this clinical study are to evaluate the safety and efficacy of a novel formulation of a non-porcine lipase, called adrulipase, in patients with EPI due to cystic fibrosis.

The main question\[s\] the study aims to answer are:

1. Is the novel formulation of adrulipase safe to use at the doses being evaluated in the clinical study.
2. Is adrulipase as effective, or more effective, compared to the pig enzymes the patients currently use.

Researchers will compare the results obtained with adrulipase to how the patients typically respond to their pig enzymes to see if adrulipase helps patients digest fats adequately and if their stomach feels good (signs and symptoms of malabsorption).

Conditions

Interventions

DRUG

adrulipase

Enteric microgranule formulation of adrulipase.

Sponsors & Collaborators

  • Entero Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2023-06-20
Completion
2023-07-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT05719311 on ClinicalTrials.gov