emugrobart (RG6237) / Roche - LARVOL DELTA

GYMINDA: A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity (clinicaltrials.gov) - P2 | N=285 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

MANOEUVRE: A Study to Evaluate RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy (clinicaltrials.gov) - P2 | N=48 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Nov 2026 ➔ May 2025

Trial primary completion date • Muscular Dystrophy

A Study to Evaluate the Effect of RO7204239 on Insulin Sensitivity and Muscle Composition in Participants With Type 2 Diabetes Mellitus (T2DM) and Overweight or Obesity (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2026 ➔ Mar 2027

Enrollment open • Trial completion date • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study to Evaluate the Effect of RO7204239 on Insulin Sensitivity and Muscle Composition in Participants With Type 2 Diabetes Mellitus (T2DM) and Overweight or Obesity (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Hoffmann-La Roche

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

GYMINDA: A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity (clinicaltrials.gov) - P2 | N=234 | Recruiting | Sponsor: Hoffmann-La Roche

New P2 trial • Genetic Disorders • Obesity

MANOEUVRE: A Study to Evaluate RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy (clinicaltrials.gov) - P2 | N=48 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: May 2025 ➔ Nov 2026

Trial primary completion date • Muscular Dystrophy

MANATEE: A Study to Investigate the Safety and Efficacy of RO7204239 in Combination With Risdiplam (RO7034067) in Participants With Spinal Muscular Atrophy (clinicaltrials.gov) - P2/3 | N=259 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Mar 2028 ➔ Feb 2029

Trial primary completion date • Genetic Disorders • Movement Disorders • Muscular Atrophy • Rare Diseases

MANATEE: A Study to Investigate the Safety and Efficacy of RO7204239 in Combination With Risdiplam (RO7034067) in Participants With Spinal Muscular Atrophy (clinicaltrials.gov) - P2/3 | N=259 | Recruiting | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Movement Disorders • Muscular Atrophy • Rare Diseases

MANATEE: A Study to Investigate the Safety and Efficacy of RO7204239 in Combination With Risdiplam (RO7034067) in Participants With Spinal Muscular Atrophy (clinicaltrials.gov) - P2/3 | N=259 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Jun 2026 ➔ Mar 2029 | Trial primary completion date: Jun 2026 ➔ Mar 2028

Trial completion date • Trial primary completion date • Genetic Disorders • Movement Disorders • Muscular Atrophy • Rare Diseases

MANATEE: A Study to Investigate the Safety and Efficacy of RO7204239 in Combination With Risdiplam (RO7034067) in Participants With Spinal Muscular Atrophy (clinicaltrials.gov) - P2/3 | N=259 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Genetic Disorders • Movement Disorders • Muscular Atrophy • Rare Diseases

MANOEUVRE: A Study to Evaluate RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy (clinicaltrials.gov) - P2 | N=48 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Oct 2026 | Trial primary completion date: Jun 2024 ➔ May 2025

Enrollment closed • Trial completion date • Trial primary completion date • Muscular Dystrophy

MANATEE: GYM329 (RO7204239) in combination with Risdiplam treatment in ambulant children with spinal muscular atrophy (SMA) (WMS 2023) - No abstract available

Clinical • Combination therapy • Genetic Disorders • Movement Disorders • Muscular Atrophy • Rare Diseases

Preclinical in vitro evaluation of immune suppression induced by GYM329, Fc-engineered sweeping antibody. (PubMed, J Toxicol Sci) - "The result of the present study demonstrated that Fc-engineered Abs with similar binding affinity to FcγRIIb had different effects. Thus, it is important to also investigate FcγR-mediated immune functions other than binding to fully understand the biological effects of Fc-engineered Abs."

Journal • Preclinical

MANOEUVRE Study Design: A Study of GYM329 (RO7204239) in Patients with Facioscapulohumeral Muscular Dystrophy (FSHD) (AAN 2023) - P2 | "The MANOEUVRE study design will be presented. Conclusions This study will provide valuable information about the PD, safety, PK and efficacy of GYM329 treatment in patients with FSHD."

Clinical • Muscular Atrophy • Muscular Dystrophy

A Study to Investigate the Safety and Efficacy of RO7204239 in Combination With Risdiplam (RO7034067) in Participants With Spinal Muscular Atrophy (clinicaltrials.gov) - P2/3 | N=259 | Recruiting | Sponsor: Hoffmann-La Roche | N=180 ➔ 259 | Trial completion date: Dec 2026 ➔ Jun 2026 | Trial primary completion date: Dec 2026 ➔ Jun 2026

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Genetic Disorders • Movement Disorders • Muscular Atrophy • Rare Diseases

A Clinical Pharmacology Study to Evaluate the Effect of GYM329 on Disuse Muscle Atrophy in Healthy Volunteer (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Chugai Pharmaceutical | Active, not recruiting ➔ Completed

Trial completion • Muscular Atrophy

A Study to Evaluate RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

Enrollment open • Muscular Dystrophy

Manoeuvre study design: A study of GYM329 (RO7204239) in patients with facioscapulohumeral muscular dystrophy (FSHD) (WMS 2022) - "The Manoeuvre study design will be presented. This study will provide valuable information about the PD, safety, PK and efficacy of GYM329 treatment in patients with FSHD."

Clinical • Muscular Atrophy • Muscular Dystrophy

A Study to Evaluate RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy (clinicaltrials.gov) - P2 | N=48 | Not yet recruiting | Sponsor: Hoffmann-La Roche

New P2 trial • Muscular Dystrophy

A Study to Evaluate the Pharmacodynamics, Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7204239 Compared with Placebo in Participants with Facioscapulohumeral Muscular Dystrophy (clinicaltrialsregister.eu) - P2 | N=48 | Ongoing | Sponsor: F.Hoffmann-La Roche Ltd

New P2 trial • Muscular Atrophy • Muscular Dystrophy • Musculoskeletal Diseases

MANATEE: GYM329 (RO7204239) in Combination with Risdiplam Treatment in Ambulant Children with Spinal Muscular Atrophy (ICNMD 2022) - No abstract available

Clinical • Combination therapy • Genetic Disorders • Movement Disorders • Muscular Atrophy • Rare Diseases

A Clinical Pharmacology Study to Evaluate the Effect of GYM329 on Disuse Muscle Atrophy in Healthy Volunteer (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Chugai Pharmaceutical | Recruiting ➔ Active, not recruiting | N=48 ➔ 30

Enrollment change • Enrollment closed • Muscular Atrophy

A Study to Investigate the Safety and Efficacy of RO7204239 in Combination With Risdiplam (RO7034067) in Ambulatory Children With Spinal Muscular Atrophy (clinicaltrials.gov) - P2/3 | N=180 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Genetic Disorders • Movement Disorders • Muscular Atrophy • Rare Diseases

MANATEE: A Study of RO7204239 in Combination with Risdiplam Treatment in Pediatric Patients with SMA (AAN 2022) - "This study will provide valuable information about safety and efficacy of RO7204239 in combination with risdiplam treatment in ambulant pediatric patients with SMA."

Clinical • Combination therapy • Genetic Disorders • Movement Disorders • Muscular Atrophy • Pediatrics • Rare Diseases

A Clinical Pharmacology Study to Evaluate the Effect of GYM329 on Disuse Muscle Atrophy in Healthy Volunteer (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Chugai Pharmaceutical | Trial completion date: Oct 2022 ➔ Mar 2023 | Trial primary completion date: Mar 2022 ➔ Jun 2022

Trial completion date • Trial primary completion date • Muscular Atrophy