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Study of glucagon effects on physical capacity in patients with heart failure with preserved ejection fraction (HFpEF) with or without liver steatosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Heart Failure with preserved Ejection Fraction (a condition where the heart's pumping ability is maintained but it cannot fill properly with blood) and Metabolic Dysfunction Associated Steatotic Liver Disease (a condition where excess fat accumulates in the liver). The study will examine how glucagon, a hormone that helps regulate blood sugar levels, affects physical performance and metabolism when given as a continuous injection under the skin.

The treatment involves using GlucaGen, which will be mixed with Human Albumin (a blood protein) solution and given through a small needle placed under the skin. The purpose is to understand how glucagon affects the body's maximum oxygen use during exercise and changes in energy usage in patients with these conditions.

During the study, participants will receive glucagon continuously for 4 hours through an injection under the skin. The researchers will measure how well patients can exercise and how their body uses energy while receiving the medication. They will also monitor how the medication moves through the body and its effects on various substances in the blood.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medical assessment

    The study focuses on patients with heart failure with preserved ejection fraction (HFpEF), with or without liver condition called metabolic dysfunction associated steatotic liver disease (MASLD).

    Your heart function and liver condition will be evaluated to confirm eligibility for the study.

  2. Step 2

    Preparation for glucagon administration

    You will receive a subcutaneous infusion (injection under the skin) of glucagon.

    The dose will be 8 ng/kg/min of glucagon.

    The infusion will last for 4 hours.

  3. Step 3

    Physical capacity measurement

    Your physical capacity will be measured through a test called VO2max, which shows how much oxygen your body can use during exercise.

    This measurement will help determine how glucagon affects your physical performance.

  4. Step 4

    Metabolic measurements

    Your energy use will be measured in calories per minute.

    Blood samples will be taken to measure glucagon levels and other substances in your blood.

    The amount of ketones (energy molecules) in your blood will be monitored.

  5. Step 5

    Study duration

    The study is scheduled to run from December 2025 to December 2026.

    Your individual participation will involve the 4-hour glucagon administration period and associated tests.

Who can join the trial?

12 criteria

  • Must be between 18 and 75 years old
  • Must be able to understand study requirements and willing to provide written consent for voluntary participation
  • Must have confirmed heart failure with preserved ejection fraction (HFpEF) with all of these:
    • Heart failure symptoms and signs
    • Left heart pumping function of 45% or higher
    • Evidence of heart dysfunction showing problems with heart filling, including elevated heart stress proteins in blood
    • Must have liver condition (MASLD) with early scarring confirmed by:
      • Special liver scan showing stiffness value of 7.23 or higher
      • Moderate fatty liver changes on scan (specific measurement between 248 and 280)
      • Must have at least one of these health conditions:
        • Body Mass Index (BMI) above 25
        • High blood sugar levels (fasting above 100 mg/dl or after meals above 140 mg/dl) or diagnosed type 2 diabetes
        • High blood pressure (above 130/85) or taking blood pressure medications
        • High blood fats (triglycerides above 150 mg/dl) or taking medication for this
        • Low good cholesterol (HDL) - below 40 for men or below 50 for women

Who cannot join the trial?

14 criteria

  • Age below 18 or above 65 years
  • Known allergic reactions to glucagon or related substances
  • Current diagnosis of type 1 or type 2 diabetes
  • History of heart attack (myocardial infarction) in the past 6 months
  • Severe kidney disease (renal impairment with estimated glomerular filtration rate below 30 mL/min)
  • Active liver disease other than MASLD (Metabolic Dysfunction Associated Steatotic Liver Disease)
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within the past 30 days
  • Current substance abuse or alcohol dependency
  • Inability to perform exercise testing due to physical limitations
  • Use of medications that could interact with glucagon
  • Uncontrolled high blood pressure (hypertension)
  • History of pancreatic disease or tumors
  • Serious mental health conditions that could affect study participation
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Investigated drugs

Glucagon is a hormone medication that helps regulate blood sugar levels. In this trial, it is administered continuously under the skin (subcutaneously). Glucagon works by signaling the liver to release stored glucose into the bloodstream. The study examines how this medication affects physical performance and metabolism in patients with heart failure with preserved ejection fraction (HFpEF), including those who may also have metabolic-associated steatotic liver disease (MASLD).

What is already known about the treatment

Glucagon - A peptide hormone administered subcutaneously that plays a crucial role in regulating blood glucose levels and energy metabolism. This medication is primarily used in clinical practice for treating severe hypoglycemia and is now being investigated for its potential benefits in heart failure patients with preserved ejection fraction (HFpEF) and metabolic liver conditions. Glucagon works by stimulating the liver to break down stored glycogen into glucose and increasing gluconeogenesis, while also having effects on cardiac function and energy metabolism. This naturally occurring hormone belongs to the class of peptide hormones and is being studied for its potential to improve physical capacity and metabolic parameters in patients with specific cardiac conditions.

Investigated diseases

  • Heart Failure with preserved Ejection Fraction (HFpEF)

    A type of heart failure where the heart muscle contracts normally but the left ventricle doesn't relax properly between beats. This condition causes the heart to pump less effectively, leading to reduced blood flow throughout the body. The heart chambers fill with less blood than normal due to the stiff heart muscle. Common symptoms include shortness of breath, fatigue, and fluid retention, particularly during physical activity.

  • Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD)

    A chronic liver condition characterized by excessive fat accumulation in the liver cells. This condition occurs in people who drink little or no alcohol but have metabolic health issues. The disease involves inflammation of the liver tissue and can lead to scarring over time. It is closely associated with obesity, high blood pressure, and type 2 diabetes.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521835-35-00Protocol codeKKB_2025_GLUPABEstimated enrolment33 patientsSponsorKatholisches Klinikum Bochum gGmbH

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