Tirzepatide Immunogenicity on Pharmacokinetics, Efficacy, and Safety: Analysis of Data From Phase 3 Studies

• Published in: The journal of clinical endocrinology and metabolism Vol. 109; no. 2; pp. 361 - 369
• Main Authors: Mullins, Garrett R, Hodsdon, Michael E, Li, Ying Grace, Anglin, Greg, Urva, Shweta, Schneck, Karen, Bardos, Jennifer N, Martins, Ricardo Fonseca, Brown, Katelyn, Calderon, Boris
• Format: Journal Article
• Language: English
• Published: US Oxford University Press 01.02.2024
• Subjects: Antibodies; Antibodies, Neutralizing; Biological products; Care and treatment; Clinical; Clinical trials; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - drug therapy; Gastric Inhibitory Polypeptide - therapeutic use; GIP protein; Glucagon; Glucagon-like peptide 1; Glucagon-Like Peptide 1 - therapeutic use; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide-2 Receptor; Humans; Hypersensitivity; Hypoglycemic agents; Hypoglycemic Agents - adverse effects; Immunogenicity; Injection; Injection Site Reaction; Pharmaceutical industry; Pharmacokinetics; Product development; Type 2 diabetes; Viral antibodies; United States; Japan; clinical trial; type 2 diabetes; incretin therapy; immunogenicity

Abstract Context Antidrug antibodies (ADA) can potentially affect drug pharmacokinetics, safety, and efficacy. Objective This work aimed to evaluate treatment-emergent (TE) ADA in tirzepatide (TZP)-treated participants across 7 phase 3 trials and their potential effect on pharmacokinetics, efficacy,...