Evidence map›Paper›PMID 31264757›Full record

Trial reportDiabetes, obesity & metabolism2019

Body weight management and safety with efpeglenatide in adults without diabetes: A phase II randomized study.

Richard E Pratley, Jahoon Kang, Michael E Trautmann, Marcus Hompesch, OakPil Han, John Stewart, Christopher H Sorli, Stephan Jacob, Kun-Ho Yoon

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Glucagon-Like Peptide-1 Receptor Agonists in Type 2 Diabetes Mellitus and Cardiovascular Disease: The Past, Present, and Future.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2022
    Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. Research Advances in Fusion Protein-Based Drugs for Diabetes Treatment.Diabetes, metabolic syndrome and obesity : targets and therapy · 2024
    Review
  20. Postmarket safety profile of suicide/self-injury for GLP-1 receptor agonist: a real-world pharmacovigilance analysis.European psychiatry : the journal of the Association of European Psychiatrists · 2023
    Article
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

9 authors.

Richard E PratleyTranslational Research Institute for Metabolism and Diabetes, AdventHealth, Orlando, Florida.ORCID 0000-0002-2912-1389
Jahoon KangClinical Research and Development, Hanmi Pharmaceutical Co., Ltd, Seoul, South Korea.
Michael E TrautmannClinical and Regulatory Development, ProSciento, Chula Vista, California.
Marcus HompeschProSciento, Chula Vista, California.
OakPil HanDepartment of Biometrics, Hanmi Pharmaceutical Co., Ltd, Seoul, South Korea.
John StewartDepartment of Biostatistics, Sanofi Canada, Laval, Quebec, Canada.
Christopher H SorliMedical Affairs, Sanofi, Bridgewater, New Jersey.
Stephan JacobPraxis für Prävention und Therapie, Villingen-Schwenningen, Germany.
Kun-Ho YoonEndocrinology and Metabolism, Catholic University of Korea, Seoul, South Korea.ORCID 0000-0002-9109-2208

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo evaluate the safety of efpeglenatide, a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA), and its effects on body weight management in adults without diabetes. MATERIALS AND

methodsIn this phase II, randomized, placebo-controlled, double-blind trial, participants with a body mass index (BMI) ≥30 kg/m

resultsOver 20 wk, all doses of efpeglenatide significantly reduced body weight from baseline versus placebo (P < 0.0001), with placebo-adjusted reductions ranging between -6.3 kg (6 mg once every 2 wk) and -7.2 kg (6 mg once weekly). Greater proportions of efpeglenatide-treated participants had body weight loss of ≥5% or ≥10% versus placebo (P < 0.01, all comparisons). Efpeglenatide led to significant improvements in glycaemic variables (fasting plasma glucose and glycated haemoglobin) and lipid profiles (cholesterol, triglycerides) versus placebo. Rates of study discontinuations as a result of adverse events ranged from 5% to 19% with efpeglenatide. Gastrointestinal effects were the most common treatment-emergent adverse events.

conclusionsEfpeglenatide once weekly and once every 2 wk led to significant body weight reduction and improved glycaemic and lipid variables versus placebo. It was also well tolerated for weight management in adults without diabetes.

Indexed as

Anti-Obesity AgentsProlineAdultBlood GlucoseFemaleHumansMaleMiddle AgedObesityWeight LossAnti-Obesity AgentsBlood GlucoseefpeglenatideProlineclinical trialdrug developmentGLP-1glycaemic controlobesity therapyweight control

Identifiers

PMID31264757
PMCPMC6851541

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.