Lilly goes head-to-head again, this time in obesity

There seems to be little Lilly enjoys more than duking it out with an opponent: in the past it has pursued head-to-head trials in Alzheimer’s, migraine and autoimmune conditions. Yesterday the group said it would start Surmount-5, a head-to-head trial of tirzepatide and Novo’s Wegovy in obesity. The design is still under wraps, but the study will use Wegovy’s highest approved dose, 2.4mg. This is a maintenance dose, so weight loss will have to be measured over the long term to provide a fair comparison. The big question for tirzepatide in obesity is whether Lilly can file before a cardiovascular outcome study read outs in 2024; execs said yesterday on an earnings call that a meeting to discuss that with the FDA will happen soon. Other obesity updates included the generic name for the triple-G agonist, retatrutide, which is already in phase 2, and that an amylin and calcitonin receptor agonist had reached phase 1. Lilly's GLP-1/glucagon agonist mazdutide is no longer listed as an obesity project in Lilly’s investor presentation, despite excellent showing on weight loss in phase 1. Chief medical officer Dan Skovronsky seemed to suggest that mazdutide might still be viable as a weight loss product, however. 

Lilly's tirzepatide trial programme 
Trial name Details N Results
Surmount-1 Vs pbo in obesity or overweight pts 2,539 Hit April 2022
Surmount-2 Vs pbo in obesity or overweight pts w type 2 diabetes 900 Expected Q2 2023
Surmount-3 Vs pbo in obesity or overweight pts after a lifestyle weight loss programme 800 Expected Q2 2023
Surmount-4 Vs pbo in obesity or overweight pts - maintenance of weight loss 750 Expected Q2 2023
Surmount-5* Head to head weight reduction trial vs Wegovy 2.4mg TBD TBD
Surmount-MMO* Morbidity and mortality obesity study TBD TBD
Surpass-CVOT Head-to-head CV outcomes in pts with type 2 diabetes, vs Trulicity 12,500 PCD Oct 2024
*Newly announced trial. Source: Evaluate Pharma, clinicaltrials.gov, company comments. Note: tirzepatide is approved in type 2 diabetes as Mounjaro.

 

And beyond tirzepatide: Lilly's other obesity projects
Phase Product Mechanism Note
Phase II LY3502970 GLP-1 agonist Also in Ph2 for type 2 diabetes
Phase II Retatrutide (LY3437943) GIP/GLP-1/
glucagon agonist
Also in Ph2 for type 2 diabetes
Phase I Dacra QW II Dual amylin and calcitonin receptor agonist  
Phase I Mazdutide (oxyntomodulin) GLP-1/
glucagon agonist
In development for type 2 diabetes only but might still be viable for obesity
Source: Evaluate Pharma, company comments. 

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