Excellence in cardiometabolic clinical trials: Two Phase Ib/2a case studies

The secrets to delivering the data required to move cardiometabolic assets from Phase 1 to 2

28

May

  • 3pm London 10am New York
  • Free
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Why attend?

Cardiometabolic drug development is in its busiest era, it started with GLP-1 receptor agonists but now extends across many different targets for MASLD and obesity therapies. This is driving an unprecedented wave of early clinical activity. Yet sponsors are often struggling. Screen failure rates above 80 percent are now routine when inclusion criteria require Fibroscan and MRI-PDFF, recruitment timelines slip, and the advanced imaging logistics overwhelm sites. It is difficult to find sites that can perform complex bedside testing such as standardized postprandial metabolic challenges, insulin sensitivity assessments, and indirect calorimetry and access to imaging such as DEXA, MRI or Fribroscan. Selecting the wrong site can cost months of development time and tens of millions in study spend.

Drawing on two recently completed Phase 2 cardiometabolic studies at Nucleus Network’s Minneapolis site, Dr Graham Wood, Chief Scientific Officer, and Dr Trisha Shamp, VP Medical Operations and US Principal Investigator, will share how an experienced clinical pharmacology unit delivered to demanding sponsor timelines. Attendees will learn how AI-enabled “look-alike” digital recruitment compressed enrolment for a MASLD study to 80 randomized participants in 16 weeks, how integrated participant engagement workflows sustained compliance above 96 percent and retention above 94 percent across both studies, and how a single site combined MRI-PDFF, whole-body MRI, Fibroscan, indirect calorimetry, and standardized postprandial metabolic challenges to deliver advanced cardiometabolic endpoints.

Whether you are designing a MASLD proof-of-concept study, a GLP-1 cessation protocol, or any complex cardiometabolic trial, this webinar will give you a practical framework for selecting and partnering with high-performing Phase 1 and Phase 2 sites. Register now to secure your place and bring your study design questions to the live Q&A.

Key Learnings:

  • Apply AI-driven digital recruitment strategies to overcome high screen failure rates in MASLD and obesity studies.
  • Design participant engagement workflows that sustain compliance above 96 percent and retention above 94 percent through long, intensive cardiometabolic protocols.
  • Plan and integrate advanced imaging and complex bedside metabolic testing including MRI-PDFF, Fibroscan, indirect calorimetry, and postprandial challenges within a single site.

Speakers

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Dr Graham Wood, PhD
Chief Scientific Officer, Nucleus Network

Dr Graham Wood is Chief Scientific Officer at Nucleus Network and brings over 26 years of clinical research experience to the role. He provides global scientific leadership, advising clients on clinical pharmacology study design and overseeing complex studies, with a particular focus on the Minneapolis clinic. He holds a PhD in Neurology and Neurosurgery from McGill University and has contributed to more than 350 first-in-human studies and over 2,000 trials in clinical pharmacology. His career includes senior executive roles in leading clinical research organizations and biotechnology companies, and his strategic leadership and operational focus continue to drive innovation across Nucleus Network’s global operations.

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Dr Trisha Shamp
VP Medical Operations and US Principal Investigator, Nucleus Network

Dr Trisha Shamp is Vice President of Medical Services for Nucleus Network’s US clinical research unit and brings over 20 years of leadership in Phase 1 to 4 clinical trials. A globally recognized leader in renal pharmacokinetics, she is sought after by pharmaceutical and biotech sponsors for her expertise in renal PK study design, execution, and regulatory strategy. Under her direction, Nucleus Network’s Minneapolis site has built a state-of-the-art dialysis program supporting renal impairment studies, and she has been instrumental in accelerating proof-of-concept studies from preclinical discovery to early-phase clinical validation. She continues to practise critical care medicine, holds certifications as a Cardiovascular PA, in Hemodialysis, and in Adult ECMO, and is passionate about integrating artificial intelligence into clinical trial design.

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