BARI-STEP V1
Research type
Research Study
Full title
BARI-STEP: A double-blinded, randomised, placebo-controlled trial of semaglutide 2.4 mg in patients with poor weight-loss following bariatric surgery.
IRAS ID
299128
Contact name
Janine Makaronidis
Contact email
Sponsor organisation
University College London Joint Research Office
Eudract number
2021-004568-83
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
U1111-1263-5209, Universal Clinical Trial Number; Z6364106/2021/06/106, Data Protection Registration
Duration of Study in the UK
2 years, 1 months, 31 days
Research summary
Obesity and its associated co-morbidities represent a global health threat causing 3.4 million preventable deaths annually. The Coronavirus Infectious Disease 2019 (COVID-19) pandemic highlighted the need to maximise health outcomes for people living with obesity, who are at an increased risk of severe disease and mortality from COVID-19. Obesity leads to a pro-inflammatory state with increased production of inflammatory cytokines, which can result in impaired immune responses. In addition to improvement in co-morbidities, weight loss following bariatric surgery has been shown to improve immune function and lower rates of hospital and intensive care admission upon COVID-19 infection.
Bariatric surgery is the most effective treatment for patients with severe obesity producing sustained weight-loss with reduced morbidity and mortality. Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are the commonest bariatric procedures. Whilst at a population level these operations are highly effective at reducing weight, obesity-associated morbidity and mortality; at the level of the individual, weight-loss following RYGB and SG is highly variable. Given the associated risks, procedure cost and the need for lifelong nutritional monitoring there is an urgent unmet clinical need to identify those with a poor weight loss response, improve weight-loss and maximise the health benefits for bariatric surgery patients.
BARI-STEP is a phase III b, double-blinded, randomised, parallel group trial in patients with poor weight loss following bariatric surgery. The aim of this trial is to determine whether 68 weeks of subcutaneous semaglutide 2.4 mg causes greater percentage weight loss and to estimate the extent of any reduction, reduction in adiposity, improvement in metabolic indices, physical function and health-related quality of life (HRQoL) than placebo in patients with poor weight loss following RYGB or SG.REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0045
Date of REC Opinion
7 Mar 2022
REC opinion
Further Information Favourable Opinion