emugrobart (RG6237)
/ Roche
- LARVOL DELTA
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November 13, 2025
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
October 08, 2025
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
September 20, 2025
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
August 23, 2025
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
May 12, 2025
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
April 11, 2025
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
March 24, 2025
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
February 24, 2025
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
December 19, 2024
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
November 29, 2024
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
April 24, 2024
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
July 26, 2023
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
July 03, 2023
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
March 12, 2023
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
March 17, 2023
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
February 17, 2023
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
December 09, 2022
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
August 20, 2022
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
September 21, 2022
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
September 08, 2022
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
July 17, 2022
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
July 07, 2022
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
April 22, 2022
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
March 06, 2022
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
February 21, 2022
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
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