GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance

What Was Tested

In this phase 2 trial, researchers set out to test Dulaglutide.

It had two arms (groups): Dulaglutide (experimental) and Observation (no intervention).

The Mixed Meal Tolerance Test as described in the primary outcome section will be performed at baseline and after 6 weeks of dulaglutide therapy in the intervention period.

The Mixed Meal Tolerance Test as described in the primary outcome section will be performed at baseline and after 6 weeks of no intervention in the observation period.

The registry classes the interventions as drug.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 1\. Male or female, aged ≥18 years on date of consent. 2\. Confirmed diagnosis of CF, defined by positive sweat test or Cystic Fibrosis transmembrane conductance regulator (CFTR) mutation analysis according to Cystic Fibrosis Foundation (CFF) diagnostic criteria. 3\. Pancreatic insufficiency defined by clinical requirement for pancreatic enzyme replacement. 4\. Abnormal glucose tolerance defined by OGTT criteria for EGI, IGT, or CFRD, or diagnosed CFRD. 5\. Ability to take subcutaneous medication and be willing to adhere to the weekly administration regimen and complete study specific procedures (MMTT).

The full record lists 8 inclusion and 15 exclusion criteria; among the exclusions: 1\. bmi \<19 kg/m2; 2\. presence of first-degree atrioventricular block or other evidence for cardiac conduction system or structural heart defects; 3\. pregnancy or lactation; a negative urine pregnancy test will be required at enrollment.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

The participants were allocated by chance, so the Dulaglutide group and the comparison group should start out alike.

Each person switched between Dulaglutide and the comparison at some point, usually with a gap in between.

Being open-label, the Dulaglutide study did not mask who received what.

It started in 2021-07-16 with completion listed for 2027-06-30.

It ran at 2 sites in United States (2).

Its stated primary purpose is other.

What Was Measured

Primary outcome: Early-phase insulin secretion (time frame: 18 weeks).

It also tracked 2 secondary outcomes, for example Early-phase insulin secretion adjusted for glucose excursion and Glucose tolerance.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Dulaglutide in 30 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Dulaglutide compound page, all human trials.