In 1997, Novo Nordisk scientist Lotte Bjerre Knudsen managed to turn the short-lived GLP-1 hormone into a long-acting drug candidate. However, the initial test failed as the dose was set too low. And the company could not immediately start a new trial. Victory is still far from assured. Follow “A steak well done”, Episode 3 of the Novo Nordisk Foundation’s 2022 Advent Calendar “The Story of GLP-1”.
00:00:01 - Introduction: GLP-1 hormone and its potential for diabetes treatment
00:00:04 - Early clinical trials with GLP-1 infusion in Miami
00:00:39 - Challenges in converting GLP-1 into a stable drug
00:01:08 - Lotter Knudson’s role and early setbacks in the project
00:01:40 - Initial failed tests due to low dosing
00:02:02 - Prioritization of insulin over GLP-1 in Novo Nordisk
00:02:20 - Controversies and skepticism within the company
00:02:50 - Discovery of calcitonin and tumor formation concerns
00:03:20 - Designing a molecule close to human GLP-1
00:03:40 - Addressing tumor formation concerns in animal studies
00:04:20 - Phase 3 trials and the ambitious LEAD program
00:04:50 - FDA advisory committee hearing and its challenges
00:05:40 - Dialogue with the FDA and overcoming regulatory hurdles
00:06:40 - Approval and launch of the GLP-1 drug
00:07:40 - Launching the drug and immediate market entry
00:08:00 - Considering GLP-1 for obesity treatment
00:08:30 - Initial skepticism and controversies about dual biology
00:09:00 - Previous failures and risks in developing obesity drugs