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GLP1R in Parkinson's Disease

Plain-language guide to NCT03659682: phase 2 randomized trial of Semaglutide, parkinson's disease, 120 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03659682
Phase
phase 2
Status
status unknown
Start
2019-01-02
Completion (planned or actual)
2024-12-31
Participants
120 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Parkinson Disease
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested Semaglutide for parkinson's disease.

The purpose of the study is to test the neuroprotective and anti-inflammatory properties of semaglutide in idiopathic Parkinson's disease (PD).

It had two arms (groups): semaglutide (active comparator) and placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The trial is a single center, double-blind, placebo-controlled study.

The researchers plan to enroll 270 newly diagnosed patents with idiopathic Parkinson's disease (PD) over 2 years.

Semaglutide has been approved by the Food and Drug Administration (FDA) and European Medicines Agency to treat adults with type 2 diabetes.

The treatment has not been approved for use in patients with PD.

Who Took Part

Enrollment: 120 planned participants were the target.

It was open to people of any sex aged from 40 years up to 75 years.

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

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the parkinson's disease participants took both Semaglutide and the comparison in turn, acting as their own control.

Neither the parkinson's disease participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-01-02 with completion listed for 2024-12-31.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Motor Function (time frame: 48 months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 120 people with parkinson's disease.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Parkinson's disease research.

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.