Humanised IgG1 monoclonal antibody against human latent myostatin for Obesity | Overweight

Inclusion criteria

• {"criterion_text":"- Able and willing to provide written informed consent, to participate in all scheduled assessments, and to comply with the study protocol according to ICH and local regulations\n- Male or female participants, aged 18 and above at the time of signing the ICF.\n- BMI ≥ 27.0 kg/m² and <30.0 kg/m² with at least one weight-related comorbidity such as hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, cardiovascular disease\n- History of at least one self-reported unsuccessful dietary or exercise effort to lose body weight\n- Weight stability: self-reported change in body weight less than 5 kg (11 lbs) within 3 months prior to screening\n- Agreement to adhere to the contraception requirements"}

Exclusion criteria

• {"criterion_text":"- Pregnant or breastfeeding, or with intention of becoming pregnant during the study or within the timeframe in which contraception is required\n- Prior history or diagnosis of diabetes mellitus (T1DM, T2DM, or rare forms of diabetes mellitus) or historical or screening laboratory values suggestive of diabetes mellitus, defined as 1 or more values of HbA1c ≥ 6.5% (48 mmol/mol), fasting plasma glucose ≥ 126 mg/dL (7.0 mmol/L), or random glucose ≥ 200 mg/dL (11.1 mmol/L)\n- Have obesity induced by other endocrinologic disorders (e.g., Cushing’s syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency [MC4R] or Prader–Willi Syndrome).\n- Participation in unbalanced/extreme diets (e.g., very low calorie, low carbohydrate, very high protein, ketogenic diets) or in an organized weight reduction program within 3 months of the screening visit or plans to engage in such diets or programs during the study.\n- Have any of the following cardiovascular conditions within 6 months prior to screening: a) Acute myocardial infarction, b) Cerebrovascular accident (stroke), c) Unstable angina, or d) Hospitalization due to congestive heart failure.\n- Have a history of NYHA Functional Classification III or IV congestive heart failure"}

Primary endpoints

• {"endpoint_text":"- Percent (%) change in body weight from baseline at Week 48","definition_or_measurement_approach":"Percent change in body weight from baseline measured at Week 48 (body weight measurement compared to baseline)."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline at Week 48 Absolute change in body weight (kg)","definition_or_measurement_approach":"Absolute change in body weight (kg) from baseline to Week 48."}
• {"endpoint_text":"- Change from baseline at Week 48 Change in body mass index (BMI) (kg/m2)","definition_or_measurement_approach":"Change in BMI (kg/m2) from baseline to Week 48."}
• {"endpoint_text":"- Change from baseline at Week 48 Waist-to-height ratio","definition_or_measurement_approach":"Change in waist-to-height ratio from baseline to Week 48 (waist circumference divided by height)."}
• {"endpoint_text":"- Change from baseline at Week 48 Waist circumference","definition_or_measurement_approach":"Change in waist circumference from baseline to Week 48 (measured circumference in cm)."}
• {"endpoint_text":"- Change from baseline at Week 48 in Total body fat mass (kg and %) by dual-energy x-ray absorptiometry (DXA)","definition_or_measurement_approach":"Total body fat mass (kg and %) measured by DXA; change from baseline to Week 48."}
• {"endpoint_text":"- Change from baseline at Week 48 in Total lean body mass (kg and %) by DXA","definition_or_measurement_approach":"Total lean body mass (kg and %) measured by DXA; change from baseline to Week 48."}
• {"endpoint_text":"- Change from baseline at Week 48 in Appendicular lean mass (kg and %) by DXA","definition_or_measurement_approach":"Appendicular lean mass (kg and %) measured by DXA; change from baseline to Week 48."}
• {"endpoint_text":"- Change from baseline at Week 48 in Muscle volume (%) by magnetic resonance imaging (MRI)","definition_or_measurement_approach":"Muscle volume (%) measured by MRI; change from baseline to Week 48."}
• {"endpoint_text":"- Change from baseline at Week 48 in Muscle fat infiltration (%) by MRI","definition_or_measurement_approach":"Muscle fat infiltration (%) measured by MRI; change from baseline to Week 48."}
• {"endpoint_text":"- Change from baseline at Week 48 in the following markers Glucose metabolism: glycated hemoglobin (HbA1c), fasting plasma glucose, fasting C-peptide, and fasting insulin; Homeostasis Model Assessment of Insulin Resistance (HOMA-IR); Quantitative Insulin Sensitivity Check Index (QUICKI)","definition_or_measurement_approach":"Changes in glucose metabolism markers (HbA1c, fasting plasma glucose, fasting C-peptide, fasting insulin) and derived indices (HOMA-IR, QUICKI) from baseline to Week 48."}
• {"endpoint_text":"- Change from baseline at Week 48 in the following markers Fasting lipid profile: total cholesterol, triglycerides, low-density lipoprotein (LDL), high-density lipoprotein (HDL), non-HDL cholesterol","definition_or_measurement_approach":"Changes in fasting lipid profile (total cholesterol, triglycerides, LDL, HDL, non-HDL cholesterol) from baseline to Week 48."}
• {"endpoint_text":"- Incidence, severity, and causal relationship of AEs as reported by the Investigator, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 (NCI CTCAE, v5.0)","definition_or_measurement_approach":"Adverse events reported by Investigator; severity graded per NCI CTCAE v5.0; incidence and investigator-assessed causality recorded."}
• {"endpoint_text":"- Change from baseline in vital signs, physical findings, ECG, and clinical laboratory results","definition_or_measurement_approach":"Changes in vital signs, physical exam findings, ECG parameters and laboratory tests from baseline (schedule unspecified here)."}
• {"endpoint_text":"- Incidence of local and systemic injection reactions","definition_or_measurement_approach":"Incidence of injection site reactions and systemic injection-related reactions reported during the study."}
• {"endpoint_text":"- Incidence of abnormal laboratory findings","definition_or_measurement_approach":"Incidence of clinically significant abnormal laboratory values during the study."}
• {"endpoint_text":"- Incidence of abnormal ECG parameters","definition_or_measurement_approach":"Incidence of abnormal ECG findings during the study."}
• {"endpoint_text":"- Incidence of abnormal vital signs","definition_or_measurement_approach":"Incidence of clinically significant abnormal vital signs during the study."}
• {"endpoint_text":"- Serum concentrations of RO7204239 at specified timepoints","definition_or_measurement_approach":"RO7204239 serum concentration measurements at specified study timepoints (PK sampling schedule not specified here)."}
• {"endpoint_text":"- PK parameters of RO7204239 including Ctrough,ss and t1/2 (if appropriate)","definition_or_measurement_approach":"Pharmacokinetic parameters for RO7204239 including trough concentration at steady state (Ctrough,ss) and half-life (t1/2) if applicable."}
• {"endpoint_text":"- Estimated PK parameters of RO7204239 using a population-PK model including AUCtau,ss, Cmax,ss, CL/F, and Vd/F","definition_or_measurement_approach":"Population PK modelling to estimate AUCtau,ss, Cmax,ss, apparent clearance (CL/F) and apparent volume of distribution (Vd/F) for RO7204239."}
• {"endpoint_text":"- Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study","definition_or_measurement_approach":"Assessment of anti-drug antibodies prevalence at baseline and incidence of ADA development during the study."}

Spain

Earliest CTIS Part Ii Submission Date

19-05-2025

Latest Decision Or Authorization Date

09-06-2025

Processing Time Days

21

Number Of Sites

10

Number Of Participants

39

Poland

Earliest CTIS Part Ii Submission Date

16-05-2025

Latest Decision Or Authorization Date

23-06-2025

Processing Time Days

38

Number Of Sites

7

Number Of Participants

39

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Main CRO

Third parties

• {"country":"United Kingdom","full_name":"Q2q Communications Limited","duties_or_roles":"Event Management - Investigator Meeting","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"IXRS provider","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient payment services (travel, accom. stipends)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"ECG Provider","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Main CRO","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging Provider","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Actigraph LLC","duties_or_roles":"Wearable device - sensor technology - movement data collection","organisation_type":"Pharmaceutical company"}