CARDIOMETABOLIC CRO

Trials that run for years need a team that stays

Event rates. Retention. Sites that stay engaged. Long trials are won or lost on all three, so the senior team you meet at the pitch stays to the last visit, across obesity, diabetes, MASH, lipids, and heart failure.

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Long-standing track record for long-term studies

100+
cardiometabolic studies in 25+ countries
2,000+
sites across Europe, the Americas, Africa, and Asia
23k+
participants enrolled across 2,000+ sites
30+
RWE studies alongside our clinical trials

Deep cardiometabolic expertise,
across the metabolic continuum

Cardiometabolic diseases rarely occur in isolation, and neither should the studies that test them. AKEURA plans each indication with specialists from endocrinology, hepatology, cardiology, and primary care, across clinical trials and real-world evidence.

Obesity

Weight loss is the start, not the endpoint

Obesity, overweight with comorbidities, and incretin and next-generation therapies

We design obesity studies for what regulators and payers ask next: body composition, cardiometabolic outcomes, and the retention that long dosing periods demand.

Diabetes

Built for the long follow-up

Prediabetes, type 1 diabetes, type 2 diabetes, and diabetes complications

From early glucose-lowering studies to long-term outcomes trials, we plan diabetes programs for durable retention, real-world follow-up, and the complications that shape the endpoint.

MASLD and MASH

Find participants before the biopsy

MASLD, MASH, MetALD, and fibrosis-stage trials, with noninvasive screening in primary care

MASH screen failure is notoriously high. We find participants through primary care with noninvasive tests, so the right people reach your sites.

Lipid disorders

Residual risk is where the work is

Hypercholesterolemia, Lp(a), hypertriglyceridemia, familial hypercholesterolemia, and statin intolerance

From LDL-C and Lp(a) to statin intolerance, we take lipid programs through to cardiovascular outcomes, with the site reach and follow-up that MACE endpoints need.

Hypertension and heart failure

Where metabolic disease meets the heart

Resistant hypertension, pediatric hypertension, HFpEF, and HFrEF

Heart failure and hypertension studies with a metabolic lens: eligibility, endpoints, and safety plans built for patients with more than one condition.

Cardiovascular outcomes

Years of follow-up. Zero room for drift.

Cardiovascular outcomes trials (CVOTs), MACE endpoints, ASCVD risk reduction, and cardiorenal complications

Event-driven trials depend on engaged sites and endpoints that hold up. We run endpoint adjudication and retention plans built for years, not months.

Bronwyn Secourgeon, MSc

Associate Vice President, Cardiometabolic Diseases

Heading the cardiometabolic business, drawing on nearly 20 years of business development across Europe and Asia-Pacific.

Diederick (Rick) E. Grobbee, MD, PhD

Chief Scientific Officer

Shaping scientific strategy across every study, backed by decades of leadership in large-scale cardiometabolic research.

Manuel Castro Cabezas, MD, PhD

Expert Scientific Officer

Practicing internist-endocrinologist and vascular specialist, now bringing clinical depth to cardiometabolic research.

Vivian de Jong, PhD

Project Manager

Clinical epidemiology research and European MASH screening study setup, now managing cardiometabolic studies end to end.

Kaatje Bollaerts

Senior Vice President, Real-World Evidence

20+ years in vaccine and infectious disease biostatistics, now leading global real-world evidence research and partnerships.

Erik van Zandbergen

Senior Vice President, Operations

Overseeing global clinical operations, drawing on a pharmacy background and 15+ years of CRO business development leadership.

The experts you meet are the experts you keep

Bronwyn Secourgeon

Global Head of Cardiometabolic Diseases

[Short bio to come.]

Professor Manuel Castro Cabezas

Scientific Officer, Cardiometabolic Diseases; Founder, GRIPonMASH;

Author (250+ publications)

Professor Rick Grobbee

Chief Scientific Officer

[Short bio to come.]

Vlad Ratziu

Hepatology Advisor

[Short bio to come.]

Jörn Schattenberg

Hepatology Advisor

[Short bio to come.]

Manuel Romero-Gómez

Hepatology Advisor

[Short bio to come.]

Christophe Moreno

Hepatology Advisor

[Short bio to come.]

Outcomes trials run for years. Teams rarely do.

Our approach

The team that pitches your study is the team that runs it, through to database lock. Senior experts sit in core roles, and you reach them directly.

Our people stay, too: just 5% voluntary turnover.

Event-driven trials lose power one dropout at a time.

Our approach

We keep sites engaged and participants in the study, with retention plans built for years and site relationships we already have.

Brought in to turn around a Phase III CVOT, we ran 200 sites across 12 countries with zero lost to follow-up.

The eligibility criteria look broad, but the participant pool is not.

Our approach

Specialist hospitals see one part of the population. Primary care networks and real-world data show us the rest.

We use both to choose sites and geographies that can actually recruit the participants your study needs.

In MASH, most people screened never randomize.

Our approach

We find participants in primary care with noninvasive tests and biomarkers, before they reach a biopsy, and send only likely candidates to your sites.

GRIPonMASH, the public-private consortium we co-founded, is putting this model to work across Europe.

Patients rarely have just one condition. Protocols often assume they do.

Our approach

Endocrinologists, hepatologists, cardiologists, and primary care physicians shape eligibility, endpoints, and safety plans together.

Comorbidities are planned for from day one, not discovered at screening.

Your clinical program sees approval as the finish line.

Our approach

Payers and regulators ask what happens next. Clinical and real-world evidence specialists plan together from the start.

The same team carries your evidence from late-phase trials into real-world studies, so it keeps working after approval.

Case study

We know where CVOTs stumble

Born at UMC Utrecht in 2008, we’ve run large outcome studies ever since. So when a mid-size biotech’s Phase III lipid-lowering trial fell behind, we stepped in, activated 200 sites across 12 countries, and turned it around without losing a single patient to follow-up.

Fact sheet

Cardiometabolic diseases rarely exist in isolation. Neither does our expertise.

Obesity, diabetes, cardiovascular disease, chronic kidney disease, and MASH share interconnected biology and overlapping patient populations. AKEURA brings scientific leadership, primary-care and specialist referral networks, and global execution to studies across the full continuum.

Case study

Speed. And certainty.

Recruiting right after an ACS event leaves a narrow window, and sites were competing for the same patients in one of the most crowded investigator landscapes in clinical research. We moved fast at start-up without cutting corners, enrolling 7,226 patients across 26 countries with adjudicated data ready for regulatory submission.

Support at every stage of development

Early phase clinical development

Confident first steps from first dose to proof of concept, with answers your next study can trust

Explore early phase

Late phase clinical development

Phase IIb to Phase IV trials at scale, built to carry your program through approval and beyond

Explore late phase

Real-world evidence studies

Regulatory-grade post-approval safety and effectiveness studies, led by RWE specialists who stay within reach

Explore real-world evidence

Frequently asked questions

Answers to your questions about our cardiometabolic expertise

Heart failure is a condition in which the heart cannot pump or fill well enough to meet the body’s needs. Some cardiometabolic studies may focus on reduced or preserved ejection fraction, symptoms, hospitalizations, cardiovascular death, and quality of life.

Metabolic dysfunction-associated steatotic liver disease (MASLD) is excess liver fat linked to metabolic risk factors. Metabolic dysfunction-associated steatohepatitis (MASH) is a more active form of the disease with liver inflammation and damage, which can progress to fibrosis, cirrhosis, and other serious complications.

AKEURA runs clinical and real-world studies in cardiovascular outcomes, heart failure, hypertension, lipid disorders, diabetes, MASLD/MASH, and related cardiometabolic and renal conditions.

A cardiovascular outcomes trial, or CVOT, tests how a medicine affects major cardiovascular events such as cardiovascular death, heart attack, or stroke. These event-driven trials are often large, global, and long because they continue until enough events occur to answer the study question.

Start with the people. Choose a CRO with experience in your indication, phase, study size, and geography. Ask who will lead the work, whether they will stay, how sites and participants will be retained, and how clinical development will connect with real-world evidence.

Cardiovascular outcomes trials often involve thousands of participants, many sites and countries, years of follow-up, and enough clinical events to answer the study question. Sponsors must closely monitor endpoint adjudication, site performance, participant retention, and event yield from start to finish.

MASLD and MASH trials can face high screening failure, changing diagnostic pathways, complex biomarkers and endpoints, and long follow-up. AKEURA puts hepatology advisors and cardiometabolic specialists on the same study to plan across liver, metabolic, and cardiovascular risk.

A registry follows a defined population and collects data over time. A database study analyzes existing sources such as claims or electronic health records. A prospective observational study enrolls participants and collects new real-world data without assigning treatment. The right design depends on the question.

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Trials that run for years need a team that stays

Long-standing track record for long-term studies

Deep cardiometabolic expertise,across the metabolic continuum

Weight loss is the start, not the endpoint

Built for the long follow-up

Find participants before the biopsy

Residual risk is where the work is

Where metabolic disease meets the heart

Years of follow-up. Zero room for drift.

The experts you meet are the experts you keep

Bronwyn Secourgeon, MSc

Diederick (Rick) E. Grobbee, MD, PhD

Manuel Castro Cabezas, MD, PhD

Vivian de Jong, PhD

Kaatje Bollaerts

Erik van Zandbergen

The experts you meet are the experts you keep

Bronwyn Secourgeon

Professor Manuel Castro Cabezas

Professor Rick Grobbee

Vlad Ratziu

Jörn Schattenberg

Manuel Romero-Gómez

Christophe Moreno

We find the risk before it finds your timeline

Outcomes trials run for years. Teams rarely do.

Event-driven trials lose power one dropout at a time.

The eligibility criteria look broad, but the participant pool is not.

In MASH, most people screened never randomize.

Patients rarely have just one condition. Protocols often assume they do.

Your clinical program sees approval as the finish line.

Proof, not promises

We know where CVOTs stumble

Cardiometabolic diseases rarely exist in isolation. Neither does our expertise.

Speed. And certainty.

Support at every stage of development

Early phase clinical development

Late phase clinical development

Real-world evidence studies

Answers to your questions about our cardiometabolic expertise

What is heart failure?

What are MASLD and MASH?

Which cardiometabolic diseases does AKEURA study?

What is a cardiovascular outcomes trial?

How should sponsors choose a CRO for a cardiometabolic study?

What makes cardiovascular outcomes trials difficult to run?

What are the main challenges in MASLD and MASH clinical trials?

What is the difference between a registry, database study, and prospective observational study?

Connect with an expert

Deep cardiometabolic expertise,
across the metabolic continuum