JUV-161 / Juvena Therapeutics - LARVOL DELTA

First-In-Human Study to Evaluate Single and Multiple Ascending Doses of JUV-161 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=72 | Active, not recruiting | Sponsor: Juvena Therapeutics | Trial completion date: Jun 2026 ➔ Sep 2026

First-in-human • Trial completion date

JUV-161 Improves Glucose Metabolism and Muscle Health as Monotherapy and in Combination in Type 2 Diabetic Mice (ENDO 2026) - "JUV-161 improves glycemic control, insulin sensitivity, skeletal muscle mass, and muscle function in a severe model of type 2 diabetes, both alone and in combination with semaglutide. By simultaneously targeting metabolic dysfunction and muscle health, JUV-161 addresses a critical unmet need in diabetes-associated muscle loss and functional decline. These findings support JUV-161 as a promising first-in-class biologic with strong translational potential in type 2 diabetes."

Monotherapy • Preclinical • Diabetes • Genetic Disorders • Metabolic Disorders • Musculoskeletal Diseases • Obesity • Type 2 Diabetes Mellitus

A Secreted Protein Therapeutic, JUV-161, Improves Muscle Structure and Function in Age-Related Sarcopenia (ENDO 2026) - "Together, these findings demonstrate that JUV-161 effectively mitigates age-related muscle wasting, improves muscle composition, and restores functional performance in a model of sarcopenia. By concurrently addressing structural, cellular, and functional deficits in aging muscle, JUV-161 emerges as a promising therapeutic candidate for sarcopenia, supporting continued translational development aimed at improving mobility, reducing frailty, and enhancing quality of life in aging populations."

Sarcopenia

Pharmacodynamic Serum Biomarker for JUV-161 - an Insulin-Like Growth Factor 2 Fusion Protein Therapeutic Treatment (ENDO 2026) - "The biomarker is also distinct from other serum-based biomarkers in that it is more readily expressed in muscle tissues as compared to the liver. The strong correlation between the pharmacodynamic response of the biomarker to the pharmacokinetics of JUV-161 make it a promising candidate for measuring IGF2 signal in vivo."

Biomarker • PK/PD data • IGF2

JUV-161 as A Disease-Modifying Therapeutic for Myotonic Dystrophy Type 1 (ENDO 2026) - "Collectively, these findings demonstrate that JUV-161 reverses both structural and functional manifestations of skeletal muscle myopathy in a rigorous and disease-relevant model of DM1. This work supports JUV-161 as a promising disease-modifying therapeutic candidate for DM1 and highlights the panCUG960/+ mouse as a valuable platform for translational neuromuscular drug development."

CNS Disorders • Genetic Disorders • Muscular Dystrophy • Musculoskeletal Diseases • Myositis • Myotonic Dystrophy

JUV-161 Preserves Muscle Mass and Function during Disuse-Induced Atrophy in Mice (ENDO 2026) - "Together, these findings demonstrate that JUV-161 preserves skeletal muscle mass, functional strength, and mobility in part by favorably modulating key molecular pathways during periods of immobilization. These results support JUV-161 as a promising biologic therapy with strong translational potential to prevent disuse-related muscle atrophy and promote functional recovery in clinical settings involving prolonged inactivity."

Preclinical • Inflammation • Muscular Atrophy • TNFA

PK and Safety of JUV-161 - an Insulin-Like Growth Factor 2 Fusion Protein Therapeutic in Healthy Human Volunteers (ENDO 2026) - "The overall safety profile from Study JUV-161-101 is unremarkable: no TEAEs have risen to the level of clinical concern and no serious TEAEs have been reported. Injection site reactions are mild and do not limit repeated dose administration of study drug."

Clinical • Hematological Disorders • IGF2