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DewDiligence

11/08/23 1:18 PM

#249652 RE: Mufaso #249610

FDA approves LLY’s Zepbound—(tirzepatide)—for weight loss and chronic weight management:

https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-zepboundtm-tirzepatide-chronic-weight

Zepbound is the same drug as LLY’s Mounjaro, which is approved for T2D. The FDA dosing recommendation for Zepbound is 5mg, 10mg, or 15mg once weekly by subcutaneous injection—titrated upward from the starting dose of 2.5mg weekly in increments of 2.5mg weekly. This is essentially the same dosing as in the FDA label for Mounjaro.

Zepbound FDA label:
https://c212.net/c/link/?t=0&l=en&o=4017561-1&h=1423994038&u=https%3A%2F%2Fpi.lilly.com%2Fus%2Fzepbound-uspi.pdf&a=Prescribing+Information
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DewDiligence

11/15/23 1:34 PM

#249750 RE: Mufaso #249610

NVO starts phase-3_trial_of CagriSema vs LLY’s Zepbound* in_non-diabetic_patients_with_BMI>=30:

https://clinicaltrials.gov/study/NCT06131437

CagriSema is a fixed-dose-combination of Cagrilintide, an amylin analogue, and 2.4mg Wegovy, dosed weekly by subcutaneous injection. I.e., CagriSema has a dual MoA that is different from any approved weight-loss drug.

In the phase-3 trial, the comparator arm is 15mg of weekly Zepbound*, the highest FDA-approved dose. The primary endpoint is % weight loss relative to baseline at 72 weeks.

*a/k/a Mounjaro (#msg-173180704).