TNF Pharmaceuticals, Inc. has initiated the first in a series of studies to evaluate the impact of its novel oral TNF-alpha (TNF-α) inhibitor drug, isomyosamine, in preserving lean muscle mass during and after GLP-1 treatment for weight loss and chronic weight management.
“The body of evidence for the GLP-1 drug class shows that up to 40% of total weight loss in GLP-1 patients is lean body mass including skeletal muscle mass,1” said Mitchell Glass, M.D., President and Chief Medical Officer of TNF. “The purpose of our clinical study series is to assess isomyosamine’s potential to preserve lean muscle mass during and following GLP-1 weight loss in chronic overweight and obese patients of all age groups.”
The first study examines TNF-α levels in patients receiving the GLP-1 agonist Wegovy® or Ozempic® who show signs of increased inflammation associated with sarcopenia, which is the progressive loss of muscle mass. Isomyosamine targets excess pro-inflammatory TNF-alpha, a primary cause of sarcopenia.
“Findings from the initial observational study will inform our forward move into multiple planned clinical studies designed to evaluate isomyosamine’s effects in our target population of GLP-1 patients,” Dr. Glass continued. “Our collaboration partner, Renova Health, is using its proprietary AI and machine learning technology to analyze and identify optimal patient pools and study sites, enabling an efficient progression of our study series over the coming months.”
"We are proud to partner with TNF to tackle the critical challenges faced by patients using GLP-1 medications,” said David Jacobs, Chief Executive Officer of Renova Health. “This collaboration is expected to allow us to leverage our advanced AI and machine learning capabilities for precise cohort selection and patient engagement, enabling us to uncover deeper, more meaningful patient insights that will enhance the study’s impact.”
Valued at $49.3 billion in 2024, the GLP-1 receptor agonist market is projected to reach $105 billion in 2029, growing at a projected compound annual growth rate (CAGR) of 19.2% from 2023 to 2029. According to the Centers for Disease Control and Prevention, obesity costs the U.S. healthcare system nearly $173 billion annually.
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