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.

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’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.

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.

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.

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.

Senseonics Loses Another Partner; Skye Hosts KOL Event and Shares DIO Data; Lilly Initiates New Ph1 Trial of Obesity Asset and Ph3 Orforglipron Trial in OA; MBX Doses First Patient with MBX 4291 

A series of cardiometabolic-related news items has been observed from Senseonics/Ascensia Diabetes Care, Skye Bioscience, Lilly, and MBX Biosciences. Below, FENIX provides highlights and insights for 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.

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.

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.

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.

Novo London, Insulet, Senseonics, and MetaVia Q2 ‘25 Earnings

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Insulet, Senseonics, and MetaVia. Below, FENIX provides highlights and insights for 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.

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.

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.

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.

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.

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.

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.

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.

Lilly’s Two New Ph3 Orforglipron Trials; Abbott’s Libre Reduces Hospitalization Risk; Metsera Registers New Obesity Study; MetaVia and Galectin Q1 ’25 Earnings 

A series of cardiometabolic-related news items has been observed from Lilly, Abbott, MetaVia, Metsera, and Galectin Therapeutics. Below, FENIX provides highlights and insights for 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.

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.