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Saxenda: Underlying Mechanisms and Clinical Outcomes

Plain-language guide to NCT02944500: phase 4 randomized trial of Liraglutide, 28 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02944500
Phase
phase 4
Status
active, not recruiting
Start
2016-11
Completion (planned or actual)
2027-06
Participants
28 (actual)
Design
randomized, quadruple-blind, other
Conditions studied
Obesity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Liraglutide.

It had two arms (groups): Liraglutide followed by placebo (experimental) and Placebo followed by liraglutide (experimental).

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 28 actual participants took part.

It was open to people of any sex aged from 18 years up to 100 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Obese: BMI\> 30 kg/m2 or \>27 kg/m2 with comorbidities (including but not limited to insulin resistance, hypertension, dyslipidemia, cardiovascular disease, stroke, sleep apnea, gallbladder disease, hyperuricemia and gout, and osteoarthritis).

The full record lists 1 inclusion and 37 exclusion criteria; among the exclusions: women who are breastfeeding, pregnant, or wanting to become pregnant; women using metal iud; moderate, or severe hepatic impairment.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Liraglutide and the comparison in turn, acting as their own control.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2016-11 with completion listed for 2027-06.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): BOLD response to food cues (time frame: 5 weeks).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 28 people.

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

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

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.