GLUCAGON for Heart failure with preserved ejection fraction (HFpEF)|Metabolic dysfunction-associated steatotic liver disease (MASLD)

Inclusion criteria

• {"criterion_text":"- Age between 18 - 80 years and able to understand the requirements of the study and willing to provide signed informed consent for voluntary participation in the study\n- Patients with clinically confirmed heart failure with preserved ejection fraction (HFpEF) by: a) Symptoms and signs of heart failure b) Left ventricular ejection fraction ≥ 45% c) Objective signs of structural and/or functional cardiac dysfunction consistent with the presence of left ventricular diastolic dysfunction/elevated left ventricular filling pressures, including elevated serum natriuretic peptides\n- Metabolic associated steatotic liver disease (MASLD) without higher-level fibrosis (F3) confirmed by o Transient elastography  Elasticity (E) ≥ 8 - And  At least stetosis I-II (CAP ≥248 - ≤ 280 dB/m) o Presence of at least 1 cardiometabolic criterion  BMI > 25 kg/m2  Fasting BG > 100 mg/dl or 2h postprandial >140mg/dl or already diagnosed type 2 diabetes mellitus  RR >130/85mmHg or under antihypertensive therapy  Fasting triglycerides > 150 mg/dl or under therapy  HDL < 40 mg/dl (m) and < 50 mg/dl (w)"}

Exclusion criteria

• {"criterion_text":"- History of acute coronary syndrome or percutaneous coronary intervention/bypass surgery or cerebrovascular event (e.g. stroke) within the last 6 months\n- Existing contraindications for carrying out a cardiopulmonary performance test\n- Pregnancy\n- Inability to give informed consent/ inability to make independent decisions\n- Substance abuse (illegal drugs)\n- Employment relationship with the sponsor or the conducting clinic\n- Known allergies or intolerances in connection with study medication\n- Simultaneous participation in another clinical trial or intervention study or participation in a clinical trial or intervention study within the last 3 months\n- Severe or high-grade heart valve stenosis and/or insufficiency\n- Left ventricular ejection fraction < 45%\n- Known significant MASLD with advanced fibrosis (grade III - IV) and/or liver cirrhosis and/or alcohol-induced liver disease\n- Known severely impaired renal function (eGFR <30ml/min according to CKD-EPI formula)\n- Known active malignant disease and/or known active underlying inflammatory or infectious disease\n- Type I diabetes mellitus or insulin-dependent type II diabetes mellitus\n- Obesity per magna (BMI >40 kg/m2)\n- Physical/physical limitations that impair mobility or performance o E.g. underlying neuromuscular diseases, anaemia (anaemia < 12 g/dl), acute and/or chronic orthopaedic diseases that restrict physical mobility/performance, congenital heart defects"}

Primary endpoints

• {"endpoint_text":"- Change in VO2max (ml/kg/min) during 4 hours of continuous subcutaneous administration of glucagon at a dose of 20 ng/kg/min.","definition_or_measurement_approach":"Measurement of change in VO2max (ml/kg/min) during the 4-hour continuous subcutaneous infusion of glucagon at 20 ng/kg/min."}

Secondary endpoints

• {"endpoint_text":"- Change in energy expenditure (kcal/min) or substrate utilisation (respiratory exchange ratio) during a 4-hour continuous subcutaneous infusion of glucagon at a dose of 20 ng/kg/min","definition_or_measurement_approach":"Measurement of energy expenditure (kcal/min) and respiratory exchange ratio during the 4-hour continuous subcutaneous infusion of glucagon at 20 ng/kg/min."}
• {"endpoint_text":"- Plasma bioavailability of glucagon (area under the curve, Cmax, Tmax) and change in plasma ketone body concentration (Cmax) during a 4-hourly continuous subcutaneous infusion of glucagon at a dose of 20 ng/kg/min.","definition_or_measurement_approach":"Pharmacokinetic measures (AUC, Cmax, Tmax) of plasma glucagon and Cmax of plasma ketone bodies during the 4-hour continuous subcutaneous infusion at 20 ng/kg/min."}

Germany

Earliest CTIS Part Ii Submission Date

28-08-2025

Latest Decision Or Authorization Date

06-03-2026

Processing Time Days

190

Number Of Sites

1

Number Of Participants

47

Primary sponsor

Full Name

Katholisches Klinikum Bochum gGmbH

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"PROFIL Institut fuer Stoffwechselforschung GmbH","duties_or_roles":"code 1; code 15 (15: Trial Submission in CTIS)","organisation_type":"Pharmaceutical company"}