Bioglutide (NA-931) / Biomed Industries - LARVOL DELTA

Biomed Industries Advances NA-931 Into Two Global Phase 3 Trials Alone and with Semaglutide and Tirzepatide for Obesity (EIN Presswire) - "BIOCOMBO-1 is a planned 68-week, randomized, double-blind, placebo-controlled, global Phase 3 study...The study is expected to enroll approximately 366 non-diabetic adults with overweight or obesity (BMI ≥30 kg/m², or ≥27 kg/m² with at least one obesity-related comorbidity)....BIOCOM-2 is a second planned 68-week, randomized, double-blind, placebo-controlled, global Phase 3 study....The study is expected to enroll approximately 360 non-diabetic adults with overweight or obesity, with endpoints aligned to BIOCOMBO-1 to enable consistent evaluation of weight loss magnitude, durability, body composition, and physical function."

New P3 trial • Obesity

Developing Topics. (PubMed, Alzheimers Dement) - P1, P2 | "The clinical findings of NA-831 and NA-931 support a potential mechanistic link between Alzheimer's disease and metabolic disorders such as obesity and diabetes. While these results are encouraging, further studies are warranted to elucidate whether this association is causal."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • IGF1

Translational Progress of NA-831, NA-911, and NA-931: Clinical Evidence Supporting a Unified Theory for Alzheimer's Disease, Stroke, and Obesity (CTAD 2025) - No abstract available

Clinical • Alzheimer's Disease • Cardiovascular • CNS Disorders • Genetic Disorders • Obesity

Associations Between Alzheimer's Disease and Obesity: Clinical Trials of NA-831 for AD and NA-931 for the Treatment of Obesity (CTAD 2025) - No abstract available

Clinical • Alzheimer's Disease • CNS Disorders • Genetic Disorders • Obesity

Obesity Drugs Over the Past 20 Years: A Meta-Analysis of Clinical Trials using ML and AI (OBESITY WEEK 2025) - "GLP-1 receptor agonists such as liraglutide, semaglutide, and tirzepatide have emerged as the most effective treatments to date, achieving 10–22% weight loss in clinical trials. Novel multi-receptor agonists—including retatrutide (GLP-1/GIP/glucagon) and the investigational NA-931 (IGF-1/GLP-1/GIP/glucagon)—demonstrate even greater promise, with weight loss exceeding 24% and favorable safety profiles. In contrast, older agents such as sympathomimetics (phentermine), lipase inhibitors (orlistat), and withdrawn serotonergic drugs (lorcaserin) have shown moderate efficacy (5–15% weight loss) but are limited by tolerability and safety concerns... GLP-1 agonists outperform traditional agents in promoting sustained weight loss and metabolic improvements; however, they are associated with gastrointestinal side effects, high costs, and rare but serious risks (e.g., pancreatitis, thyroid tumors). Sympathomimetics raise cardiovascular concerns, while orlistat often results in poor..."

Retrospective data • Cardiovascular • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Pancreatic Cancer • Pancreatitis • Solid Tumor • Thyroid Gland Carcinoma • IGF1

Oral quadruple receptor agonist confers weight loss with minimal GI adverse events (Healio) - "In the efficacy estimand, mean change in body weight at 13 weeks was 5.5% with 60 mg NA-931, 8.7% with the 90 mg dose, 11.3% with 120 mg NA-931, and 13.8% with the 150 mg dose, compared with a 1.9% weight change for placebo. Both the 120 mg dose group (P = .002) and the 150 mg dose group (P = .001) had greater weight loss than placebo...When the four NA-931 groups were pooled together, a lower percentage of adults receiving the study drug reported nausea (7.3% vs. 10.3%), vomiting (5.2% vs. 6.9%) and diarrhea (6.3% vs. 6.9%) compared with placebo. All reports of nausea in the trial were deemed mild. There were three participants receiving NA-931 who reported constipation compared with none in the placebo group....Based on phase 2 data, Biomed Industries plans to advance NA-931 to phase 3 trials, Tran said."

New P3 trial • P2 data • Obesity

Associations Between Alzheimer's (AD) and Obesity: Phase 2 of NA-831 for AD and NA-931for Obesity (OBESITY WEEK 2025) - P2 | "Both NA-831 and NA-931 showed promising clinical outcomes in their respective target populations, with unexpected weight loss benefits observed in the AD trial. These findings point to a potential biological link between Alzheimer's disease, obesity, and metabolic disorders like diabetes. Further research is warranted to clarify the nature and direction of this relationship."

P2 data • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Diabetes • Genetic Disorders • Mental Retardation • Metabolic Disorders • Movement Disorders • Obesity • Parkinson's Disease • Psychiatry • Schizophrenia • IGF1

Phase 2 Trial of Oral NA-931 in Obese Subjects With at Least One Weight-related Comorbid Condition (OBESITY WEEK 2025) - P2 | "The objective of the Phase 2 clinical trial is to evaluate the efficacy and safety of once-daily oral administration of NA-931 for obesity treatment. (ClinicalTrials.gov ID NCT06564753)"

Clinical • P2 data • Genetic Disorders • Obesity • IGF1

Association between Alzheimer's disease and obesity: clinical trials of NA-831 for AD and clinical trials of NA-931 for obesity (EASD 2025) - P2 | "The clinical findings of NA-831 and NA-931 suggest a potential link between Alzheimer's disease, diabetes, and obesity. However, further research is needed to determine whether this association is causal."

Clinical • Diabetes • Metabolic Disorders • Obesity • IGF1

Phase 2 clinical trials of NA-931 to study subjects who are obese with at least one weight-related comorbid condition (EASD 2025) - P2 | "The topline results of the Phase 2 trial support NA-931 as a promising first-in-class oral quadruple receptor agonist for weight loss, demonstrating excellent efficacy and safety. The company is advancing NA-931 to Phase 3 trials."

Clinical • P2 data • Diabetes • Metabolic Disorders • Obesity • Pancreatitis • IGF1

Biomed Industries, Inc. Advances First-of-Its-Kind Oral NA-931 and Semaglutide Combination Therapy for Treating Obesity (EIN Presswire) - "These monotherapy and combination findings will be further evaluated in Biomed’s Phase 3 clinical program, expected to begin in the coming months."

New P3 trial • Obesity

Biomed Industries to Present Four Studies at AAIC 2025 on Breakthrough Alzheimer’s, Rett Syndrome, and Obesity Therapies (Firstwordpharma Press Release) - "Biomed Industries...announced it will present four major scientific papers at the Alzheimer’s Association International Conference (AAIC), taking place July 27–31, 2025, in Toronto, Canada...Featured AAIC 2025 Presentations: 1. The End of the Amyloid Era? Evidence for a Paradigm Shift in the Quest to Treat Alzheimer’s Disease; 2. A Phase 3 Clinical Protocol of NA-831 Combined with Donanemab in Early Alzheimer’s Disease: A Placebo-Controlled, Double-Blind Study; 3. Associations Between Alzheimer’s Disease and Rett Syndrome: Clinical Trials of NA-831 and NA-921; 4. Neuro-Metabolic Link Between Alzheimer’s Disease and Obesity: Clinical Evaluation of NA-831 and NA-931"

Clinical protocol • Trial status • Alzheimer's Disease • CNS Disorders • Obesity

Phase 2 Clinical Trials Of Na-931 To Study Subjects Who Are Obese With At Least One Weight-related Comorbid Condition (ENDO 2025) - "The topline results of the Phase 2 of NA-931 showed its potential as a first-in-class oral quadruple receptor agonist for weight loss, with excellent safety and efficacy. The Company is advancing NA-931 to Phase 3 trials."

Clinical • Late-breaking abstract • P2 data • Genetic Disorders • Obesity • IGF1

Phase 2 Clinical Trials of NA-931 to Study Subjects Who Are Obese with at Least One Weight-Related Comorbid Condition (ADA 2025) - P2 | "The topline results of the Phase 2 of NA-931 showed its potential as a first-in-class oral quadruple receptor agonist for weight loss, with excellent safety and efficacy. The Company is advancing NA-931 to Phase 3 trials."

Clinical • Late-breaking abstract • P2 data • Metabolic Disorders • Obesity • IGF1

Associations between Alzheimer's Disease (AD) and Obesity—Clinical Trials of NA-813 for AD and NA-931 for Obesity (ADA 2025) - P2 | "Associations of Alzheimer's disease and diabetes obesity have been suggested with clinical results of NA-831 and NA-931. However, whether this association is causal requires further evaluation."

Clinical • Late-breaking abstract • Diabetes • Metabolic Disorders • Obesity • IGF1

NA-931, a Novel Quadruple IGF-1-1, GLP-1, GIP, and Glucagon Receptor Agonist Reduces Body Weight without Muscle Loss (ADA 2025) - "We are conducting a Phase 2 trial with the oral formulation of NA-931 for the possible treatment of obesity."

Metabolic Disorders • Obesity • IGF1

Phase 2 Trials of NA-931 to Study Subjects Who Are Obese With at Least One Weight-related Comorbid Condition (clinicaltrials.gov) - P2 | N=126 | Completed | Sponsor: Biomed Industries, Inc. | Recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

Biomed Industries, Inc. to Present Phase 2 Results on NA-931—An Oral Alternative to Injectables for Obesity—at ADA 2025 (EIN Presswire) - "Biomed Industries...will present results from its Phase 2 clinical trial of NA-931, a first-in-class oral quadruple receptor agonist for the treatment of obesity, at the 85th Scientific Sessions of the American Diabetes Association (ADA), taking place June 20–23, 2025, in Chicago, Illinois....The Phase 2 study was a randomized, double-blind, placebo-controlled, parallel-arm clinical trial evaluating the safety, tolerability, efficacy, pharmacodynamics, and pharmacokinetics of NA-931 in adults with obesity (BMI ≥30 kg/m²) or who are overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity."

P2 data • Obesity

Developing Topics. (PubMed, Alzheimers Dement) - "An association of Alzheimer's disease and diabetes obesity has been suggested with clinical results of NA-831 and NA-931. However, whether this association is causal requires further evaluation."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Diabetes • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • IGF1

NA-931-200: Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese (clinicaltrials.gov) - P2 | N=224 | Not yet recruiting | Sponsor: Biomed Industries, Inc.

New P2 trial • Genetic Disorders • Obesity

T2DM: Phase 1 to Study Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NA-931 in Obese Participants and Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=74 | Completed | Sponsor: Biomed Industries, Inc.

New P1 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus