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Pressure test your investment thesis.

Investigate opportunities and keep selected diligence files current as clinical, competitive, and access developments challenge your thesis.

Investment thesis · DAPA-MI
EU trial register · Results and amendment history

Does DAPA-MI still test the outcome in our thesis?

The primary endpoint changed to a seven-component cardiometabolic composite. The original cardiovascular endpoint became secondary.

View source 23 February 2023 amendment
Revise the assumption and retain the evidence

Real source evidence.
Illustrative team files and assessments.

3 files updated
investment_committee.pptxUpdated
Investment committee / DAPA-MI02

Primary-endpoint success will require a component-level review.

Primary-endpoint success will require a component-level review.
Clinical diligence questionDAPA-MI protocol
What does the primary endpoint measure?CV death or HF hospitalization7-component cardiometabolic composite¹
Where is the CV composite tested?Primary endpointSecondary endpoint¹
Which results need separate review?CV death and HF hospitalizationMetabolic and cardiovascular components of the composite
¹ EU trial register · Results and amendment history · Source retained with the edit
clinical_diligence.xlsxUpdated
DAPA-MI · Trial design
DAPA-MI · Trial design
RowAB
1Protocol itemDAPA-MI
2Primary endpointCV death or HF hospitalization7-component cardiometabolic composite¹
3CV composite hierarchyPrimarySecondary¹
4Analysis to requestComponent-level results
Trial designSources
diligence_memo.docxUpdated

Clinical diligence

DAPA-MI · Protocol amendment

Thesis assumption under review
The primary endpoint directly tests cardiovascular death or HF hospitalization.The primary endpoint combines metabolic and cardiovascular outcomes. The CV death/HF hospitalization endpoint is secondary.¹

Open diligence questionHow much of a positive composite result would be driven by cardiovascular events?

¹ Source linked1

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Examine trial design, populations, endpoints, and access assumptions. Make the unresolved questions explicit.

Diligence memo
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Carry the evidence from first look to committee.

01

Screen

Your team brings

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Assess fit against your criteria and the relevant company and asset landscape.

A researched shortlist
02

Investigate

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Trace claims to publications, trials, product information, and market evidence.

A comparison you can inspect
03

Challenge

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An explicit evidence gap list
04

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The questions behind the thesis
01

What would substantiate the clinical claim?

02

Which competitor evidence changes the thesis?

03

Do access or partnering terms change the opportunity?

Does DAPA-MI still test the outcome in our thesis?

The primary endpoint changed. Reassess the cardiovascular thesis against the original outcome, now a secondary endpoint.

Wclinical_diligence.docx Updated
DAPA-MI · CLINICAL THESIS01

Endpoint assumptions

Maven · 1 sourced edit
The primary endpoint directly tests cardiovascular death or HF hospitalization.The primary endpoint is a 7-component cardiometabolic composite. Assess the cardiovascular thesis against the separate CV death or HF hospitalization endpoint, now secondary.1
Evidence stays attached to the edit
¹ EU trial register · DAPA-MIProtocol amendment · 23 Feb 2023+

The registry records a February 2023 amendment prompted by a lower-than-expected blinded event rate. The primary endpoint became a hierarchical cardiometabolic composite assessed using a win-ratio analysis. The original cardiovascular endpoint became secondary. The registry results were published on 7 July 2024.

EU trial register · Amendment 23 Feb 2023
Sourced revisions preserve the evidence behind each change.

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