Saxenda in Obesity Services (STRIVE Study)

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide for fat loss, obesity & body recomposition.

A two year, parallel, two group, open-label, real-world randomised controlled trial (RCT) design for subjects with severe and complex obesity who are referred to a Tier 3 or equivalent specialist weight management/obesity service.

It had two arms (groups): one (experimental) and Standard Care (active comparator).

Standard Tier 3 obesity specialist service care.

The registry classes the interventions as drug and other.

More on the Plan

The total duration of participation will be 104 weeks (+/-2 weeks).

Participants will be randomised in a 2:1 fashion to either the intervention (targeted prescribing pathway + standard care) or control (standard care) group (2 intervention: 1 control).

The control group will receive standard care in a specialist obesity service (Tier 3 or equivalent), according to the best practice in each site and can include total or partial meal replacement strategies.

The intervention group will receive the same standard care as the control group (i.e. according to the best practice in each site) plus all participants will initially receive LIRA with pre-specified stopping rules.

Who Took Part

Enrollment: 392 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Be aged between 18-75 years old (inclusive). Understand written and spoken English. Be able to give in informed consent. A body mass index ≥35 kg/m2,. Have been referred to Tier 3 weight management or equivalent service in one of the five participating sites,.

The full record lists 11 inclusion and 26 exclusion criteria; among the exclusions: diagnosis of type 1 diabetes; type 2 diabetes with treatment on dpp-iv or insulin currently; treatment with glp-1 receptor agonists within the last 6 months and/or have a history of glp-1 receptor agonist intolerance.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the fat loss, obesity & body recomposition participants stayed in one arm throughout.

Nothing was hidden in this open-label Liraglutide study: the fat loss, obesity & body recomposition participants and staff both knew the treatment.

It started in 2017-11-28 with completion listed for 2021-02-28.

It ran at 5 sites in United Kingdom (4) and Ireland (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 77 secondary outcomes, for example Participant Attendance at Appointments (Intention to Treat), Participant Attendance at Appointments (Intention to Treat), Cessation of Treatment Due to Adverse Effects (Intention to Treat), Cessation of Treatment Due to Adverse Effects (Intention to Treat), Participant Compliance With Treatment (Intention to Treat) and Participant Compliance With Treatment (Intention to Treat).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 392 people with fat loss, obesity & body recomposition.

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

More context: the Liraglutide compound page, Fat loss, obesity & body recomposition research.