Tag Archives: orforglipron

New Orforglipron SUI Trial; Amgen VESALIUS-CV Results; EASO Recommends GLP-1RAs

Three cardiometabolic-related news items have been observed: Lilly initiated the Ph3 RESTRAIN-SUI study investigating orforglipron (QD oral GLP-1RA) in female participants with obesity or overweight and stress urinary incontinence (SUI; view CT.gov record); Amgen’s Repatha met primary endpoints for its Ph3 VESALIUS-CV trial in a primary prevention population (view press release); and EASO published a framework for obesity management, recommending semaglutide and tirzepatide as first-line AOMs (view publication). Below, FENIX provides highlights and insights for the respective news items.

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Lilly’s $6.5B Orforglipron Manufacturing Site; Novo Registers Ph2 Study of Triple Agonist; Ascletis Pharma Ph1 Results; Veru Progresses Enobosarm to Ph2b; FDA Delays T1DM Sota Decision; New O5 DTC Ad During NFL Sunday 

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Ascletis Pharma, Veru, Lexicon Pharmaceuticals, and Insulet. Below, FENIX provides highlights and insights for the respective news items.

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EASD 2025 Key Press Releases (September 17)

On the third day of EASD 2025, four key news items were observed from Lilly, FDA, and Regeneron Pharmaceuticals. Below, FENIX provides context and analysis for the announcements, including thoughts on how orforglipron could potentially be approved as early as YE 2025.

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Lilly’s Ph3 ATTAIN-2 Results Set the Stage for Obesity Global Regulatory Filings 

Lilly announced topline results from the Ph3 ATTAIN-2 study evaluating orforglipron (QD oral GLP-1RA) in patients with obesity or overweight with T2DM, demonstrating mean body reductions of up to -10.5% after 72 weeks of treatment (view CT.gov record). Recall, earlier this month, Lilly shared topline results from the Ph3 ATTAIN-1 study, which evaluated orforglipron in non-T2DM participants with overweight or obesity (previous FENIX insight). Of note, Lilly’s stock is up ~5% today following the readout. Below, FENIX provides highlights and insights from the ATTAIN-2 topline results.

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Lilly Leaves Door Open for Novo; Lilly Q2 ‘25 Earnings

Lilly hosted its Q2 ‘25 earnings call (press release; slides) and provided updates across its CVRM portfolio. Separately, Lilly announced topline results from its Ph3 ATTAIN-1 trial evaluating orforglipron in 3,127 non-T2DM obese adults (view press release; CT.gov record). Of note, Lilly’s stock is down -15% due to the lower-than-expected ATTAIN-1 weight loss, despite raising revenue guidance. Below, FENIX provides highlights and insights from the call and data readout.

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Lilly ADA 2025 Investor Event; Efsitora Alfa QW Insulin Ph3 Data

Lilly hosted its ADA 2025 investor call and provided updates across its obesity portfolio, including orforglipron, retatrutide, and other early pipeline assets (view webcast). Lilly separately announced the presentation of Ph3 QW insulin efsitora alfa data (view press release). Of note, Ken Custer, Lilly’s new BU head for Cardiometabolic Health (previous FENIX insight), presented to investors for the first time. Below, FENIX provides an overview of the Lilly ADA investor event.

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ADA 2025 Key Press Releases (June 21)  

On the second day of the ADA 2025 conference, six cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, Vertex Pharmaceuticals, Senseonics, Medtronic, and Corxel Pharmaceuticals. Below, FENIX provides context and analysis for the announcements.

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