Diabetes, obesity & metabolism · 2026
Eloralintide, a selective, long-acting amylin receptor agonist for treatment of obesity: Phase 1 proof of concept.
СтатьяРандомизированное исследованиеКлиническое исследование I фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Bhattachar Shobha, Tham Lai San, Tidemann-Miller Beth, Ibriga Hilda, Qu Hongchang, Briere Daniel A, Haupt Axel, Mather Kieren J, Pratt Edward
Аннотация
AIM: Eloralintide (LY3841136) is a potent, long-acting selective amylin receptor agonist currently under development for the treatment of obesity with once-weekly subcutaneous dosing.
MATERIALS AND METHODS: This 12-week Phase 1, randomised, placebo-controlled, participant- and investigator-blinded, multiple ascending dose study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamic profiles of eloralintide upon once-weekly subcutaneous dosing without dose escalation in participants with obesity or overweight.
RESULTS: From 30 March 2022 to 25 January 2024, at three centres in the United States, 100 participants with a mean age of 44 years, 29% female participants, and mean body mass index of 32.6 kg/m2, were randomly assigned to receive either eloralintide or placebo in 5 multiple ascending dose cohorts. At Week 12, AUCτ,ss and Cmax were dose proportional with ratios of dose-normalised geometric means of 1.1 and 1.0, respectively. The most common treatment-emergent adverse events (TEAEs) with eloralintide included decreased appetite (19% of participants), headache (12%), fatigue (11%), and COVID-19 (11%). Gastrointestinal adverse events, including diarrhoea (10% of participants), nausea (8%), and vomiting (4%), were infrequent in those receiving eloralintide. Most TEAEs were mild in severity. No deaths and one serious adverse event (in the 6 mg eloralintide cohort) unrelated to eloralintide occurred. At Week 12 with eloralintide, the least squares mean percent reduction in body weight across the dose groups ranged from 2.6% to 11.3%.
CONCLUSION: Eloralintide once weekly was well tolerated with minimal gastrointestinal adverse events and resulted in clinically meaningful weight loss.
MATERIALS AND METHODS: This 12-week Phase 1, randomised, placebo-controlled, participant- and investigator-blinded, multiple ascending dose study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamic profiles of eloralintide upon once-weekly subcutaneous dosing without dose escalation in participants with obesity or overweight.
RESULTS: From 30 March 2022 to 25 January 2024, at three centres in the United States, 100 participants with a mean age of 44 years, 29% female participants, and mean body mass index of 32.6 kg/m2, were randomly assigned to receive either eloralintide or placebo in 5 multiple ascending dose cohorts. At Week 12, AUCτ,ss and Cmax were dose proportional with ratios of dose-normalised geometric means of 1.1 and 1.0, respectively. The most common treatment-emergent adverse events (TEAEs) with eloralintide included decreased appetite (19% of participants), headache (12%), fatigue (11%), and COVID-19 (11%). Gastrointestinal adverse events, including diarrhoea (10% of participants), nausea (8%), and vomiting (4%), were infrequent in those receiving eloralintide. Most TEAEs were mild in severity. No deaths and one serious adverse event (in the 6 mg eloralintide cohort) unrelated to eloralintide occurred. At Week 12 with eloralintide, the least squares mean percent reduction in body weight across the dose groups ranged from 2.6% to 11.3%.
CONCLUSION: Eloralintide once weekly was well tolerated with minimal gastrointestinal adverse events and resulted in clinically meaningful weight loss.