Roundtable Discussion 2: Assessing the Comorbidities Associated with Obesity (HF and CKD Focus)

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Roundtable Discussion 2: Assessing the Comorbidities Associated with Obesity (HF and CKD Focus)

Session Chair(s)

Jingyu (Julia) Luan, PhD

Executive Regulatory Science Director, BioPharmaceuticals R&D

AstraZeneca, United States

Brad Jordan, PhD

Associate Vice President, Regulatory Policy and Strategy

Eli Lilly and Company, United States

Fady Tanios, PhD, MSc

US Early Assets Therapeutic Area Lead - Cardio-Renal-Metabolic

Boehringer Ingelheim, United States

Topics for discussion:

Clinical Trial Design:

How do we more efficiently develop innovative medications for patients with overlapping obesity and related comorbidities such as CKD, HF, MASH, OSA and others (e.g., make the placebo smaller)?

Given the evolving evidence on the interrelationship between HF, CKD, MASH and other metabolic diseases, how can we more efficiently design and conduct outcome driven clinical trials in patients with obesity and these conditions to obtain related indications?

Current and Future Endpoints to Assess Comorbid Conditions:

Outcomes trials are long and costly, so avenues toward the development of surrogate endpoints for the evaluation of obesity-related conditions are needed that can facilitate these studies – is that possible in the near-term?

Are there any emerging surrogate endpoints that regulators may find potentially useful that could be supported through additional data generation efforts?

Where are the opportunities for collaboration that can help identify and validate these potential surrogate endpoints?

Definition of comorbid conditions of interest – what are the requirements? Is there a way to impact public health more broadly by addressing that issue? Focus on the principle, not the concept

One Trial for Multiple Indications and Labeling

What are the challenges and opportunities in designing trials that address multiple indications within a single study?

How should we approach the inclusion of other obesity-related comorbidities, such as MASH, sleep apnea, arthritis, and psoriasis, in a single clinical trial? What can we learn from oncology trials such as basket design and apply in obesity trial design?

How can we ensure that the chosen endpoints provide meaningful insights into both the primary and secondary effects of the treatment?

Speaker(s)

Speaker

Charu Gandotra, MD, MS

FDA, United States

Lead Physician, DCN, CDER

Speaker

Aliza M. Thompson, MD, MS

FDA, United States

Director of the Division of Cardiology and Nephrology, OND, CDER

Speaker

Jeffrey Nahum Siegel, DrMed, MD

FDA, United States

Director, Office of Drug Evaluation Sciences, OND, CDER

Speaker

Sylvia Gonsahn-Bollie, MD

Eli Lilly, United States

Executive Director, Clinical Research Physician

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Executive Roundtable: Shaping the Future of Obesity Drug Development