Evidence mapPaperPMID 29926478Full record

Trial reportBritish journal of clinical pharmacology2018

MEDI0382, a GLP-1/glucagon receptor dual agonist, meets safety and tolerability endpoints in a single-dose, healthy-subject, randomized, Phase 1 study.

Philip D Ambery, Sebastian Klammt, Maximillian G Posch, Marcella Petrone, Wenji Pu, Cristina Rondinone, Lutz Jermutus, Boaz Hirshberg

Open access · bronzeAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 1 pooled it
5.5field-weighted citation impact, top 3% 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.

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

37 citing papers in PubMed, 1 synthesis or guideline pooled it, 73 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Acute Effects of Glucagon on Reproductive Hormone Secretion in Healthy Men.The Journal of clinical endocrinology and metabolism · 2020
    Trial
  4. Trial
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Incretin-based therapy: a new horizon in diabetes management.Journal of diabetes and metabolic disorders · 2024
    Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. Review
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

8 authors at 3 institutions in 3 countries.

Philip D AmberyCardiovascular, Renal, and Metabolism iMED, MedImmune Ltd, Cambridge, UK.
Sebastian KlammtCharité Research Organisation GmbH, Berlin, Germany.
Maximillian G PoschCharité Research Organisation GmbH, Berlin, Germany.
Marcella PetroneCardiovascular, Renal, and Metabolism iMED, MedImmune Ltd, Cambridge, UK.
Wenji PuCardiovascular, Renal, and Metabolism iMED, MedImmune Inc, Gaithersburg, MD, USA.
Cristina RondinoneCardiovascular, Renal, and Metabolism iMED, MedImmune Inc, Gaithersburg, MD, USA.
Lutz JermutusCardiovascular, Renal, and Metabolism iMED, MedImmune Ltd, Cambridge, UK.
Boaz HirshbergCardiovascular, Renal, and Metabolism iMED, MedImmune Inc, Gaithersburg, MD, USA.
Altimmune (United States) · USMetabolism and Renal Physiology · FRCharité - Universitätsmedizin Berlin · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsMEDI0382 is a balanced glucagon-like peptide-1/glucagon receptor dual agonist under development for the treatment of type 2 diabetes mellitus and non-alcoholic steatohepatitis. The primary objective was to assess the safety of MEDI0382 in healthy subjects.

methodsIn this placebo-controlled, double-blind, Phase 1 study, healthy subjects (aged 18-45 years) were randomized (3:1) to receive a single subcutaneous dose of MEDI0382 or placebo after ≥8 h of fasting. The study consisted of six cohorts that received study drug at 5 μg, 10 μg, 30 μg, 100 μg, 150 μg or 300 μg. The primary objective was safety and tolerability. Secondary endpoints included assessments of pharmacokinetics and immunogenicity. All subjects were followed for up to 28 days.

resultsA total of 36 subjects received MEDI0382 (n = 6 per cohort) and 12 subjects received placebo (n = 2 per cohort). Treatment-emergent adverse events (TEAEs) occurred more frequently with MEDI0382 vs. placebo, which was mostly due to an increased occurrence at MEDI0382 doses ≥150 μg. All TEAEs were mild or moderate in severity. The most common TEAEs were vomiting, nausea and dizziness. There appeared to be a dose-dependent increase in heart rate with MEDI0382 treatment. MEDI0382 showed linear pharmacokinetic profile (time to maximum plasma concentration: 4.50-9.00 h; elimination half-life: 9.54-12.07 h). No immunogenicity was observed in the study.

conclusionsIn this single-dose, Phase 1 study in healthy subjects, the safety and pharmacokinetic profiles of MEDI0382 support once-daily dosing and further clinical development of MEDI0382.

Indexed as

AdultDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleGlucagon-Like Peptide 1Half-LifeHealthy VolunteersHumansHypoglycemic AgentsInjections, SubcutaneousMalePeptidesReceptors, GlucagonYoung AdultcotadutideGlucagon-Like Peptide 1Hypoglycemic AgentsPeptidesReceptors, Glucagondiabetesdrug safetypharmacokinetics-pharmacodynamicsPhase 1randomized controlled trial

Identifiers

PMID29926478
PMCPMC6138475
OpenAlexW2808959426

What Socratic holds

Textmetadata
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.