Tag Archives: tirzepatide

Lilly Initiates Tirzepatide Obesity Trial in Adolescents; Survodutide CVOT Observed; FDA Creates New Digital Health Advisory Committee; Better Therapeutics Announces AspyreRx Subgroup Topline Results; Virta Partners with Navitus for T2DM and Obesity

Five cardiometabolic-related news items have been observed: Lilly initiated a Ph3 study evaluating tirzepatide vs. placebo in adolescents who have obesity or are overweight with weight-related comorbidities (SURMOUNT-ADOLESCENTS; view CT.gov record); BI’s SYNCHRONIZE-CVOT, evaluating survodutide in people with overweight or obesity with CVD, CKD, or at least two risk factors for CVD was observed on CT.gov (view CT.gov record); FDA announced the creation of a new Digital Health Advisory Committee (view press release); Better Therapeutics announced topline results from a subgroup analysis of AspyreRx in T2DM (view press release); and Navitus Health Solutions announced a partnership with Virta Health to make Virta’s T2DM health solutions available to Navitus clients (view press release). Below, FENIX provides highlights and insights into the respective news items.

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FDA Approves Jardiance for Adults with CKD; Abbott Completes Bigfoot Acquisition; Insulet Publishes “Market Opportunity & Impact of GLP-1s” Presentation; Lilly initiates Ph3 H2H Orforglipron vs. Semaglutide and New Ph3b Tirzepatide Max Dose Study in Obesity

A series of cardiometabolic-related news items have been observed from BI/Lilly, Abbott, Insulet, and Lilly. Below, FENIX provides highlights and insights into the respective news items.

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Ypsomed Signs Long-Term Autoinjector Supply Deal with Novo; Lilly Files Lawsuits Over Copycat Mounjaro Products

Two cardiometabolic-related news items have been observed: Ypsomed announced it has signed a long-term supply agreement with Novo Nordisk to manufacture autoinjectors for various metabolic drugs currently undergoing clinical trials (view press release); and Lilly has recently sued 10 medical spas, wellness centers, and compounding pharmacies for selling unapproved and compounded versions of tirzepatide (view article). Below, FENIX provides highlights and insights into the respective news items.

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Lilly Initiates New Ph2 Study Investigating High Doses of Tirzepatide in Patients with T2DM and Obesity; Gan & Lee Doses First Patient in Ph2 QW Insulin Study; BMS discontinues NASH asset

Three cardiometabolic-related news items have been observed: Lilly initiated a Ph2 study to investigate high doses of tirzepatide in patients with T2DM and obesity that are on metformin (view CT.gov record); Gan & Lee announced the first subject has been dosed in its Ph2 study evaluating QW insulin, GZR4, in 130 Chinese adult subjects with T2DM (view press release); and BMS disclosed it is terminating its program evaluating HSP47 in NASH during its R&D day (view article). Below, FENIX provides highlights and insights into the respective news items.

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Lilly Up Big Following Q2 ’23 Results and SELECT Data Readout

Lilly hosted its Q2 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Of note, Mounjaro led Lilly’s new products category with WW Q2 ’23 sales reaching nearly $1B. Following the Q2 ’23 beat, increased FY 2023 guidance, and bolstered by Novo’s SELECT readout (previous FENIX insight), Lilly’s stock jumped +15% to an all-time high of ~$521/share. Unsurprisingly, Lilly also provided commentary surrounding the SELECT data readout. Below, FENIX provides highlights and insight from the call, including additional thoughts on the evolving obesity CVOT dynamic.

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Lilly Completes Tirzepatide Obesity Trials; Teladoc, Viking, and Roche Q2 ‘23 Earnings

Four cardiometabolic-related news items have been observed: Lilly announced topline results from SURMOUNT-3 and SURMOUNT-4, demonstrating up to 26.6% mean weight loss (view press release); Teladoc Health (press release; slides), Viking Therapeutics (press release), and Roche (press release; slides) hosted their respective Q2 ‘23 earnings calls. Below, FENIX provides highlights and insights into the respective news items.

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ADA 2023 Key Press Releases (June 24)

On the second day of ADA 2023, ten cardiometabolic-related news items were observed from Lilly, Zealand, BI, Novo Nordisk, Biomea Fusion, Sciwind Biosciences, Medtronic, Vertex, and Esperion. Below, FENIX provides context and analysis for the announcements.

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Lilly to Use PRV for Tirzepatide Obesity Submission Following Positive SURMOUNT-2 Topline Results; Lilly, Viking, and Teladoc Q1 ’23 Earnings

Four cardiometabolic-related news items have been observed: Lilly announced tirzepatide’s SURMOUNT-2 trial showed -15.7% weight loss in obese adults and said it will use a PRV for an obesity PDUFA date by YE 2023 (view press release); and Lilly (press release; slides), Viking Therapeutics (press release) and Teladoc Health (view press release; slides) hosted their respective Q1 ’23 earnings calls. Below, FENIX provides highlights and insights into the respective news items. 

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Lilly Initiates SURMOUNT H2H Obesity Trial vs. Wegovy; Lannett Delisted from NYSE; Novo Initiates Ph3 Icodec ONWARDS 9 CGM Trial; Senate Targets PBMs

A series of cardiometabolic-related news items have been observed: Lilly has initiated a fifth trial in the Ph3 SURMOUNT obesity program evaluating tirzepatide vs. Wegovy in non-T2DM obese patients (SURMOUNT-5; view CT.gov record); Lannett announced NYSE has commenced proceedings to delist its common stock (view press release); Novo Nordisk has initiated a Ph3 trial evaluating flash glucose monitoring based titration of QW insulin icodec in insulin-naïve T2DM participants (ONWARDS 9; view CT.gov record); the Senate Finance Committee has released a framework to target PBMs and reduce drug costs for patients and taxpayers (view here); and Senator Bernie Sanders’s team announced that the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing on Wednesday, May 10, at 1:00 PM EST where the CEOs of Lilly, Novo, Sanofi, and senior executives from major PBMs will testify (view article). Below, FENIX provides highlights and insights into the respective news items:

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