Saxenda in Obesity Services (STRIVE Study)

Sponsor
University of Leicester
Study ID
NCT03036800
Phase
PHASE4
Status
Completed

Conditions

  • Diabetes Mellitus
  • Obesity
  • Weight Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Saxenda — DRUG
    standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose)
  • Specialist Obesity Management Services — OTHER
    Specialist Obesity Management Services standard of care

Study Details

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. Participants will be randomised to receive 1) standard care (obesity-specialist care), or 2) targeted prescribing pathway (obesity-specialist care plus targeted use of Liraglutide 3.0mg \[LIRA 3mg\] with pre-specified stopping rules for the medication). The aim of the study is to compare the effectiveness, budget impact, and cost-effectiveness between the two groups in a real-world setting among otherwise largely unselected patients.

Key Dates

Start date
Nov 28, 2017
Status verified
Jan 2023
Primary completion
Feb 28, 2021
Completion
Feb 25, 2022

Study Design

Enrollment
392 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
    Standard care plus targeted use of the intervention Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply
  • Active Comparator: Standard Care
    standard Tier 3 obesity specialist service care

Primary Outcome Measure

Weight Loss of ≥15% From Baseline (Complete Cases) [ Time Frame: 52 weeks ]

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