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The study demonstrated that NA-931 achieved a clinically meaningful weight loss of -6.4% or 5.1% relative to placebo after 28 days of treatment (p < 0.001). Importantly, NA-931 showed no significant gastrointestinal-related adverse events and no muscle loss, positioning it as a well-tolerated and promising option for weight management.
Study Highlights:
The Phase I trial was a randomized, double-blind, placebo-controlled study conducted in participants who were overweight or obese, including those with type 2 diabetes. NA-931, a small molecule quadruple receptor agonist, is being developed for the treatment of both type 2 diabetes and obesity.
Body Weight Reduction:
Results from the 28-day multiple ascending dose (MAD) study showed dose-dependent reductions in body weight. Participants treated with NA-931 experienced mean weight reductions of up to 6.8% , or 5.1% relative to placebo (p < 0.001).
Following this 28-day period, participants entered an 8-week open-label extension, extending the total treatment duration to 12 weeks. During this 12-week MAD study, participants receiving 150 mg of NA-931 daily achieved a body weight reduction of up to 12.7%, or 10.4% relative to placebo.
Safety and Tolerability:
28-Day Study:
NA-931 was well tolerated, with all reported treatment-emergent adverse events (TEAEs) rated as insignificant or mild. Of these, 86% were considered insignificant. Mild nausea was reported in 8.3% (1 of 12) of participants at the highest dose (150 mg/day) and in 3.7% (2 of 54) of participants overall. No vomiting occurred, even at the highest dose of 150 mg/day. Diarrhea was reported in 8.3% (1 of 12) of participants at the highest dose, and in 3.7% (1 of 54) of participants overall.
12-Week Study:
During the 12-week study, 78% of TEAEs were insignificant or mild. Mild nausea was reported in 16.6% (2 of 12) of participants at the highest dose and 6.8% (3 of 44) of participants overall. No vomiting occurred, and diarrhea was reported in 8.3% (1 of 12) of participants at the highest dose, and in 4.5% (2 of 44) of participants overall.
Pharmacokinetic Profile:
Pharmacokinetic data supports a once-daily dosing regimen for NA-931. Blood levels of the drug remained consistent regardless of fasting or after a high-fat meal, suggesting that NA-931 can be taken without regard to meal timing, offering greater flexibility for patients.
Conclusion and Next Steps:
The Phase I study results indicate that NA-931 not only holds promise for weight loss but also for glycemic control in individuals with type 2 diabetes.
“The Phase 1 results underscore the potential of NA-931 as a first-in-class oral quadruple receptor agonist, with promising efficacy and safety. ” said Dr. Lloyd L. Tran, Chief Executive Officer of Biomed Industries, Inc. “We believe NA-931, with its excellent safety profile, could represent a valuable treatment option for patients with obesity.”
Biomed Industries plans to present the full study data at an upcoming medical conference. A Phase 2 clinical trial of NA-931 for obesity treatment is currently underway, with top-line results expected in the first quarter of 2025.
The Growing Need for Obesity Treatment:
Obesity is one of the most urgent global health challenges, associated with comorbidities such as type 2 diabetes, cardiovascular disease, liver disease, and chronic kidney disease. By 2035, over 50% of the global population—more than four billion people—are expected to be affected by obesity or overweight.
About the NA-931 Study:
The NA-931-050 trial is a Phase I randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of NA-931 in otherwise healthy adults who are overweight or obese, with or without type 2 diabetes. The full clinical protocol is available at ClinicalTrials.gov (ID: NCT06615700).
About Biomed Industries, Inc.:
Biomed Industries, Inc. is a pioneering biopharmaceutical company dedicated to developing and commercializing novel therapeutics to address unmet medical needs. The company’s innovative research platform has led to the development of treatments for conditions including Alzheimer’s disease, ALS, Traumatic Brain Injury, Major Depressive Disorder (MDD), Diabetes, Obesity, MASH, Stroke, and rare diseases such as Rett Syndrome.
For more information, visit our official website :
https:// www.biomedind.com
CONTACT
Michael Willis
Biomed Industries, Inc.
San Jose, CA 95131 USA
Tel: 800-824-5135
Email: [email protected]
Website: https://www.biomedind.com
Dr. Lloyd L. Tran
Biomed Industries, Inc.
+1 800-824-5135
email us here
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