Evidence mapPaperPMID 32441473Full record

Trial reportObesity (Silver Spring, Md.)2020

Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5.

Robert F Kushner, Salvatore Calanna, Melanie Davies, Dror Dicker, W Timothy Garvey, Bryan Goldman, Ildiko Lingvay, Mette Thomsen, Thomas A Wadden, Sean Wharton and 2 more

5 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Obesity (Silver Spring, Md.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03548935. Cited by 114 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
114citing papers in PubMed, 4 pooled it
24.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03548935 phase3completed

Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity

Ran2018Enrolled1,961Registered outcomes42Posted comparisons4ConditionsMetabolism and Nutrition Disorder, Overweight or ObesityArmsPlacebo (semaglutide), semaglutide
PMID 33567185other papers from this trial
Open the trial in the graph
NCT03548987 phase3completed

Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity Who Have Reached Target Dose During run-in Period

Ran2018Enrolled902Registered outcomes37Posted comparisons2ConditionsMetabolism and Nutrition Disorder, ObesityArmsPlacebo, semaglutide
PMID 33755728other papers from this trial
Open the trial in the graph
NCT03552757 phase3completed

Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity and Type 2 Diabetes

Ran2018Enrolled1,210Registered outcomes41Posted comparisons4ConditionsObesity, OverweightArmsPlacebo II (Semaglutide), Placebo I (Semaglutide), Semaglutide 1.0 mg, Semaglutide 2.4 mg
PMID 33667417other papers from this trial
Open the trial in the graph
NCT03611582 phase3completed

Effect and Safety of Semaglutide 2.4 mg Once-weekly as Adjunct to Intensive Behavioural Therapy in Subjects With Overweight or Obesity

Ran2018Enrolled611Registered outcomes31Posted comparisons4ConditionsObesity, OverweightArmsPlacebo (semaglutide), semaglutide
PMID 33625476other papers from this trial
Open the trial in the graph
NCT03693430 phase3completed

Two-year Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity

Ran2018Enrolled304Registered outcomes37Posted comparisons4ConditionsObesity, OverweightArmsPlacebo (semaglutide), semaglutide
PMID 36655300other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

114 citing papers in PubMed, 4 syntheses or guidelines pooled it, 269 citations in OpenAlex.

  1. Pooled it
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54 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 10 institutions in 5 countries.

Robert F KushnerDivision of Endocrinology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.ORCID 0000-0002-1380-3705
Salvatore CalannaNovo Nordisk A/S, Søborg, Denmark.
Melanie DaviesDiabetes Research Centre, University of Leicester, Leicester, UK.
Dror DickerDepartment of Internal Medicine, Hasharon Hospital Rabin Medical Center, Petah Tikva, Israel.
W Timothy GarveyDepartment of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, Alabama, USA.ORCID 0000-0003-0822-0860
Bryan GoldmanNovo Nordisk A/S, Søborg, Denmark.
Ildiko LingvayDepartment of Internal Medicine/Endocrinology, UT Southwestern Medical Center, Dallas, Texas, USA.
Mette ThomsenNovo Nordisk A/S, Søborg, Denmark.
Thomas A WaddenDepartment of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Sean WhartonYork University and Wharton Weight Management Clinic, Toronto, Ontario, Canada.ORCID 0000-0003-0111-1530
John P H WildingObesity and Endocrinology Research, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.
Domenica RubinoWashington Center for Weight Management and Research, Arlington, Virginia, USA.
Novo Nordisk (Denmark) · DKNorthwestern University · USSouthwestern Medical Center · USTel Aviv University · ILUniversity of Alabama at Birmingham · USUniversity of Leicester · GBUniversity of Liverpool · GBUniversity of Pennsylvania · USWashington Center for Weight Management and Research · USYork University · CA

Funding

UAB Nutrition Obesity Research Center (NORC)P30DK056336 · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 2000 to 2025
$6.0M
UAB Diabetes Research CenterP30DK079626 · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 2025 to 2025
$1.3M
NIDDK NIH HHS P30 DK056336NIDDK NIH HHS P30 DK079626Novo Nordisk
6 · The paper itself

Abstract

objectiveThe obesity epidemic is a public health concern, warranting further research into pharmacological treatments for weight management (WM) as an adjunct to lifestyle interventions. The Semaglutide Treatment Effect in People with obesity (STEP) program aims to investigate the effect of semaglutide versus placebo on weight loss, safety, and tolerability in adults with obesity or overweight.

methodsAcross five phase 3 trials (NCT03548935, WM; NCT03552757, WM in type 2 diabetes; NCT03611582, WM with intensive behavioral therapy; NCT03548987, sustained WM; and NCT03693430, long-term WM), ~5,000 participants are being randomly assigned to receive semaglutide 2.4 mg once weekly subcutaneously versus placebo. Results will be available in 2020/2021. For all trials, the primary end point is change from baseline to end of treatment in body weight.

resultsParticipants have a mean age of 46.2 to 55.3 years, are mostly female (mean: 74.1%-81.0%), and have a mean BMI of 35.7 to 38.5 kg/m

conclusionsThe STEP program evaluates the efficacy and safety of semaglutide 2.4 mg subcutaneously once weekly in a broad population. The trials will provide insights on WM in people with obesity with and without type 2 diabetes and on long-term follow-up.

Indexed as

Diabetes Mellitus, Type 2Double-Blind MethodFemaleGlucagon-Like PeptidesHumansHypoglycemic AgentsMaleMiddle AgedObesitySemaglutideTreatment OutcomeGlucagon-Like PeptidesHypoglycemic AgentsSemaglutide

Identifiers

PMID32441473
PMCPMC7318657
OpenAlexW3028216699

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.