Impact of Glucagon on Physical Capacity and Metabolism

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Katholisches Klinikum Bochum gGmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

14 Nov 2025 → ongoing

Decision date (initial)

2025-09-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Others, Efficacy

To investigate the metabolic effects and impact on physical performance as measured by VO2max of continuously subcutaneously administered glucagon in HFpEF patients with and without concomitant MASLD.

Conditions and MedDRA coding

Heart Failure with preserved Ejection Fraction (HFpEF) with or without concomitant Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 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
2. 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
3. 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 16

1. History of acute coronary syndrome or percutaneous coronary intervention/bypass surgery or cerebrovascular event (e.g. stroke) within the last 6 months
2. Severe or high-grade heart valve stenosis and/or insufficiency
3. Left ventricular ejection fraction < 45%
4. Known significant MASLD with advanced fibrosis (grade III - IV) and/or liver cirrhosis and/or alcohol-induced liver disease
5. Known severely impaired renal function (eGFR <30ml/min according to CKD-EPI formula)
6. Known active malignant disease and/or known active underlying inflammatory or infectious disease
7. Type I diabetes mellitus or insulin-dependent type II diabetes mellitus
8. Obesity per magna (BMI >40 kg/m2)
9. 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
10. Existing contraindications for carrying out a cardiopulmonary performance test
11. Pregnancy
12. Inability to give informed consent/ inability to make independent decisions
13. Substance abuse (illegal drugs)
14. Employment relationship with the sponsor or the conducting clinic
15. Known allergies or intolerances in connection with study medication
16. Simultaneous participation in another clinical trial or intervention study or participation in a clinical trial or intervention study within the last 3 months

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in VO2max (ml/kg/min) during 4 hours of continuous subcutaneous administration of glucagon at a dose of 20 ng/kg/min.

Secondary endpoints 2

1. 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
2. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Katholisches Klinikum Bochum gGmbH

Sponsor organisation

Katholisches Klinikum Bochum gGmbH

Address

Gudrunstrasse 56, Grumme Grumme

City

Bochum

Postcode

44791

Country

Germany

Scientific contact point

Organisation

Katholisches Klinikum Bochum gGmbH

Contact name

Prof. Dr. med. Arash Haghikia

Public contact point

Organisation

Katholisches Klinikum Bochum gGmbH

Contact name

Prof. Dr. med. Arash Haghikia

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications