trevogrumab (REGN1033) / Regeneron, Sanofi - LARVOL DELTA

Select Upcoming 2025 Milestones (GlobeNewswire) - "Report additional data from Phase 1/2 study for DB-OTO (AAV-based gene therapy) in patients with hearing deficit due to variants of the otoferlin gene (mid-2025); Report results from Phase 3 study for pozelimab (C5 antibody) in combination with cemdisiran in myasthenia gravis (second half 2025)....Report results from Phase 2 study for semaglutide in combination with trevogrumab (myostatin antibody) with and without garetosmab (Activin A antibody) in obesity (second half 2025); Report results from Phase 2 study for mibavademab (LEPR agonist antibody) in combination with tirzepatide in obesity (second half 2025); Report results from Phase 3 study for garetosmab (Activin A antibody) in fibrodysplasia ossificans progressiva (FOP) (second half 2025)."

Clinical data • Myasthenia Gravis • Obesity • Rare Diseases

The impact of weight loss on fat-free mass, muscle, bone and hematopoiesis health: Implications for emerging pharmacotherapies aiming at fat reduction and lean mass preservation. (PubMed, Metabolism) - "Novel compounds in the pipeline, such as Bimagrumab, Trevogrumab, and Garetosmab-which inhibit activins and myostatin signaling-have demonstrated promise in preventing muscle loss while promoting fat loss...Since this dual therapeutic approach could help address the challenges of muscle and bone loss during weight loss, well-designed studies are needed to optimize these strategies and assess long-term benefits. For the time being, considerations like advanced age and prefrailty may affect the choice of suitable candidates in clinical practice for current and emerging anti-obesity medications due to the associated risk of sarcopenia."

Journal • Review • Cardiovascular • Diabetes • Genetic Disorders • Hematological Disorders • Metabolic Disorders • Obesity • Osteoporosis • Sarcopenia

COURAGE: A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss and Fat Loss (clinicaltrials.gov) - P2 | N=999 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Combined GDF8 and Activin A Blockade in Healthy Volunteers: Safety, Efficacy, and Pharmacokinetics (OBESITY WEEK 2024) - "In healthy participants, trevogrumab and garetosmab were generally well tolerated. Combination tx led to greater-than-additive increases in muscle mass, with reductions in fat. Results suggest that GDF8 and activin A are key negative regulators of muscle mass in humans and that combination blockade may be a promising therapeutic approach in muscle atrophy and obesity settings."

Clinical • PK/PD data • Genetic Disorders • Muscular Atrophy • Obesity

COURAGE: A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss and Fat Loss (clinicaltrials.gov) - P2 | N=999 | Recruiting | Sponsor: Regeneron Pharmaceuticals | N=624 ➔ 999 | Trial primary completion date: Jun 2026 ➔ Feb 2026

Enrollment change • Trial primary completion date • Genetic Disorders • Obesity

COURAGE: A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss and Fat Loss (clinicaltrials.gov) - P2 | N=624 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

The Effect of Combined Activin A and Myostatin Blockade on Body Composition—A Phase 1 Trial (ADA 2024) - "Combined administration of trevogrumab and garetosmab led to dose-dependent, greater‑than‑additive increases in TMV and lean mass, while decreasing fat mass in healthy participants."

P1 data • Diabetes • Metabolic Disorders

COURAGE: A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss and Fat Loss (clinicaltrials.gov) - P2 | N=624 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

COURAGE: A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss and Fat Loss (clinicaltrials.gov) - P2 | N=624 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

COURAGE: A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss and Fat Loss (clinicaltrials.gov) - P2 | N=624 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P2 trial • Genetic Disorders • Obesity

Study of Safety, Tolerability, and Pharmacokinetics of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women and Healthy Adult Men (clinicaltrials.gov) - P1; N=82; Completed; Sponsor: Regeneron Pharmaceuticals; Active, not recruiting ➔ Completed

Clinical • Combination therapy • Trial completion

Safety and Efficacy of REGN2477+REGN1033 in Patients With Sporadic Inclusion Body Myositis (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: Regeneron Pharmaceuticals; N=120 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal