Tag Archives: tirzepatide

Lilly Ph3 Tirzepatide SUPRASS-1 Data Lives up to Ph2b Hype

Lilly announced topline results from the first tirzepatide Ph3 study, SURPASS-1. The study demonstrated up to a -2.1% reduction in A1C and -9.5kg weight loss with 15mg tirzepatide, according to the trial product estimand (e.g. per-protocol analysis). Full results from the SURPASS-1 trial are scheduled to be presented at the ADA 2021 conference (June 25-29). Of note, Lilly has also recently initiated three additional Ph3 studies in the tirzepatide obesity program (SURMOUNT 2, 3, and 4). Below, FENIX provides a SURPASS-1 comparative analysis, including thoughts on tirzepatide in the context of high-dose Ozempic, high-dose Rybelsus, and high-dose Trulicity.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Summary of Tirzepatide SURPASS Ph3 Event

Today, Lilly hosted a webcast presenting an overview of the Ph3 tirzepatide SURPASS program. Of note, Lilly highlighted that topline data from SURPASS-1 is anticipated in mid-December 2020 with US/EU filing in late 2021/early 2022. Below, FENIX provides highlights from the call as well as insights into the incretin dynamics in the T2DM space.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Lilly, Novartis, Pfizer, and Merck Q3 ’20 Earnings Updates

Lilly, Novartis, Pfizer, and Merck each hosted their respective Q3 ’20 earnings calls and provided updates across a variety of topics. Importantly, it was disclosed that FDA has requested an advisory committee meeting to discuss Novartis’s Entresto PARAGON-HF submission. Below, FENIX provides highlights and insights from the respective earnings calls.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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New Tirzepatide + Glargine U100 vs. Basal-Bolus Trial (SURPASS-6)

A new CT.gov record has been observed for a Lilly-sponsored Ph3 trial (SURPASS-6) comparing the safety and efficacy of tirzepatide vs. insulin lispro U100 in T2DM patients inadequately controlled on glargine U100 with or without metformin. Below, FENIX provides an overview of SURPASS-6 as well as insight into why the trial makes sense in the context of similar LCM trials conducted for Ozempic, Trulicity, Tanzeum, and Bydureon.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Tirzepatide CVOT Underway; Dexcom G6 CE Mark for Wear on Upper Arm; Nemaura Medical to Join Russell Indices

A series of diabetes-related news has been observed: Lilly announced it has dosed the first patient in the tirzepatide SURPASS-CVOT study, Dexcom received CE Mark for the G6 CGM to be worn on the back of the upper arm, and Nemaura Medical is set to join the Russell 2000 Index and Russell 3000 Index. Below, FENIX provides highlights and insights from the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Thoughts on High-dose Trulicity Data

Late last week, Lilly announced that results from the AWARD-11 high-dose Trulicity trial had been published, with data showing up to -1.9% reduction in A1C and -10.4lb weight loss at 36 weeks with the 4.5mg dulaglutide dose (previous FENIX insight). Below, FENIX has conducted an AWARD-11 comparative analysis and provides thoughts on high-dose Trulicity in the context of Novo’s Ozempic and Lilly’s tirzepatide.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Empa T1DM Discontinued; Lilly Q1 ’20 Earnings Update; AZ Initiates Farxiga COVID-19 Trial

Lilly hosted its Q1 ’20 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that the empa T1DM program has been discontinued. Separately, AstraZeneca announced plans to evaluate Farxiga as a treatment for hospitalized COVID-19 patients who are at increased risk of complications, such as organ failure. The trial is being conducted at Saint Luke’s Mid America Heart Institute and led by Mikhail Kosiborod. Below, FENIX provides highlights and insights from the Lilly earnings call as well as thoughts on the new AZ trial.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Tirzepatide CVOT Record Available on CT.gov

A new CT.gov record for Lilly’s tirzepatide CVOT (SURPASS CVOT) has been observed. The trial details are consistent with Lilly’s discussion during its recent Q4 ’19 earnings call. Below, FENIX provides an overview and brief thoughts on the SURPASS CVOT study.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Lilly and Roche Q4 ’19 Earnings Updates

Lilly and Roche hosted their respective Q4 and FY 2019 earnings calls and provided updates to their respective diabetes businesses. Of note, Lilly disclosed additional information regarding the impending initiation of the tirzepatide T2DM CVOT, and Roche indicated it plans to pursue smartphone pump control. Below, FENIX provides highlights and insights from the calls including thoughts on how Lilly’s tirzepatide CVOT trial design compares to the 2008 FDA Guidance.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Tirzepatide CVOT vs. Trulicity; Lilly 2020 Guidance Summary

Today, Lilly hosted its 2020 Guidance and Investment Community Meeting and discussed potential key milestones for 2020. Importantly, Lilly disclosed that its tirzepatide CVOT will be conducted H2H vs. Trulicity. Below, FENIX provides highlights and insights from the call including thoughts on why a tirzepatide CVOT vs. Trulicity makes sense.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.