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Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity

Plain-language guide to NCT04074161: phase 3 randomized trial of Semaglutide and Liraglutide, 338 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04074161
Phase
phase 3
Status
completed
Start
2019-09-11
Completion (planned or actual)
2021-03-27
Participants
338 (actual)
Design
randomized, quadruple-blind, treatment
Conditions studied
Overweight; Obesity
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Semaglutide and Liraglutide.

This study will look at participants' body weight from the start to the end of the study.

The study will last for about 1½ years.

This is to compare the effect on body weight in people taking semaglutide once a week or people taking liraglutide once every day.

It had four arms (groups): Semaglutide (experimental), Placebo (semaglutide) (placebo comparator), Liraglutide (active comparator) and Placebo (liraglutide) (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

338 actual participants took part.

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: Male or female, age 18 years or older at the time of signing informed consent. History of at least one self-reported unsuccessful dietary effort to lose body weight.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: history of type 1 or type 2 diabetes mellitus; A self-reported change in body weight of more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

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

It started in 2019-09-11 with completion listed for 2021-03-27.

It ran at 19 sites in United States (19).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide [amount hidden] Versus Liraglutide [amount hidden]).

It also tracked 31 secondary outcomes, for example Change From Baseline (Week 0) to Week 68 in Waist Circumference, Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg)), Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure, Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure, Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline) and Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide and Liraglutide in 338 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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

Our Notes on the Compounds

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

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.