Efficacy and safety of glucagon-like peptide-1/glucagon receptor co-agonist JNJ-64565111 in individuals with obesity without type 2 diabetes mellitus: A randomized dose-ranging study.

Autor: Alba M; Janssen Research & Development, LLC, Raritan, New Jersey, USA., Yee J; Janssen Research & Development, LLC, Raritan, New Jersey, USA., Frustaci ME; Janssen Research & Development, LLC, Spring House, Pennsylvania, USA., Samtani MN; Janssen Research & Development, LLC, Raritan, New Jersey, USA., Fleck P; Janssen Research & Development, LLC, Raritan, New Jersey, USA.
Jazyk: angličtina
Zdroj: Clinical obesity [Clin Obes] 2021 Apr; Vol. 11 (2), pp. e12432. Date of Electronic Publication: 2021 Jan 21.
DOI: 10.1111/cob.12432
Abstrakt: Individuals with obesity have a heightened risk of developing serious comorbidities, and pharmacological treatments for people with obesity are limited. This phase 2 study assessed the safety and efficacy of JNJ-64565111, a dual agonist of glucagon-like peptide-1 and glucagon receptors, in individuals with class II/III obesity without type 2 diabetes. In this randomized, double-blind, placebo-controlled and open-label active-controlled, parallel-group, multicentre study, participants aged 18 to 70 years with a body mass index of 35 to 50 kg/m 2 and stable weight were randomly assigned in a 1:1:2:2:2 ratio to blinded treatment with placebo; JNJ-64565111 (5.0, 7.4 or 10.0 mg, each with no dose escalation), or open-label liraglutide 3.0 mg. The primary efficacy endpoint was percent change from baseline in body weight at week 26. Four-hundred seventy four participants were randomized and 343 (72.4%) completed treatment. At week 26, placebo-subtracted body weight changes (adjusted for multiplicity) were -6.8%, -8.1% and -10.0% for the JNJ-64565111 5.0 mg, 7.4 mg and 10.0 mg groups, respectively, and -5.8% for the liraglutide group. Incidence of treatment-emergent adverse events, especially nausea and vomiting, was higher in each JNJ-64565111 treatment group compared to placebo and liraglutide. JNJ-64565111 significantly reduced body weight in a dose-dependent manner vs placebo but was associated with greater incidence of treatment-emergent adverse events.
(© 2021 World Obesity Federation.)
Databáze: MEDLINE
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