Metabolic Associated Fatty Liver DiseaseNCT07246421
Glucagon Resistance in Patients With MASLD and T2DM
A study testing Glugagon in people with Metabolic Associated Fatty Liver Disease and Type 2 Diabetes (T2DM), run by University of Aarhus at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to investigate the sensitivity to glucagon in patients with type 2 diabetes mellitus (T2DM), with and without metabolic associated fatty liver disease (MASLD). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Metabolic Associated Fatty Liver Disease, Type 2 Diabetes (T2DM)
- What is being tested?
- Glugagon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Jan 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 26 kg/m²
- confirmed diagnosis of Type 2 Diabetes Mellitus (T2DM) min. 6 months prior enrollment
- steatosis FF% > 5,6% on MR spectroscopy for MAFLD group
Who cannot join
- Alcohol abuse (>10 units per week for both sexes) or other substance abuse
- Smoking
- Current or previous malignant disease
- Blood donation within the last 3 months prior to the study day
- Participation in studies involving radioactive isotopes within the past 3 months
- Pregnancy
Show all 16Show fewer
- Severely dysregulated type 2 diabetes mellitus (haemoglobin A1c ≥ 100 mmol/mol)
- C-peptide < 200 pmol/L
- Previous acute myocardial infarction (AMI)
- Clinical symptoms of heart failure
- Current or previous malignant disease
- Known ongoing systemic disease, except for dyslipidaemia and hypertension
- Regular use of medication that may affect lipid and glucose metabolism, including insulin treatment, regular use of over-the-counter medications, and hormonal contraception. Exceptions:
- Participants treated with statins may be included following a 2-week washout period prior to the experimental study day.
- Participants receiving oral glucose-lowering therapy for T2DM and antihypertensive medication may be included provided that medication is withheld on the study day only.
- Participants receiving weekly injectable glucagon-like peptide-1 receptor agonists (GLP-1 analogues) may be included following a 1-week washout period prior to the study day.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8000
Kia E. Fonfara, Medical Doctor, +4524607114, kia.eistrup@clin.au.dk
About this study
Official title: Mechanisms for Glucagon Resistance as Driver of Metabolic Associated Steatotic Liver Disease and Cardiovascular Disease in Humans With Type 2 Diabetes
The goal of this clinical trial is to investigate the sensitivity to glucagon in patients with type 2 diabetes mellitus (T2DM), with and without metabolic associated fatty liver disease (MASLD).
The main questions it aims to answer are:
Read more
- Is the sensitivity to glucagon with respect to hepatic FA oxidation and suppression of VLDL-TG secretion impaired in humans with T2DM and MASLD?
- Is glucagon resistance and MASLD reflected in an aberrated lipidomic/metabolomic profile in blood and adipose tissue?
Researchers will compare patients with T2DM with and without MASLD to see if the response to basal and high levels of glucagon differs between the groups.
Participants will attend 2 short visits and 1 full-day visit, including:
- Body scan (DXA) to check fat and bone composition
- MRI to measure liver fat.
- Blood tests.
- Ultrasound to check liver stiffness and scarring.
- Fat biopsies
- 8-hour hormone (including glucagon) and tracer infusion
- PET-CT scans
- Being tested
- Glugagon
- Keywords
- MASLD, Glucagon, Glucagon Resistance
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlugagonOther
Infusion of low dose glucagon and high dose glucagon during simultaneous somatostatin infusion and replacement doses of insulin and growth hormone. Infusion of palmitate, VLDL-triglyceride and glucose tracers.
[11C]palmitate PET during low and high dose glucagon.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with T2DM and MR spectroscopy verified NO steatosis | Active comparator | Not described Receives: Other: Glugagon |
| Subjects with T2DM and MR spectroscopy verified steatosis | Active comparator | Not described Receives: Other: Glugagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic FFA oxidation rate (µmol/100Ml/min)
Measured using [11C]palmitate positron-emission tomography (PET)
Measured: 30 minutes at steady-state
Blood and adipose tissue proteomic and lipidomic profiles
Mass spectrometry-based lipidomic/proteomic profiles of paired adipose and plasma samples.
Measured: 30 minutes after steady-state
Secondary outcomes (3)
Endogen glucose production (mmol/kg/min)
3-3H glucose tracer technique
Measured: 30 minutes at steady-state
Fatty acid turnover (µmol/min)
Infusion af [9,10-3H] palmitate and measurement of specific activity
Measured: 30 minutesat steady-state
VLDL-triglyceride kinetics (appearance rate (µmol/min) and oxidation (µmol/min))
Ex vivo labeled VLDL [14C]-triolein tracer technique. Oxidation is measured by specific activity in exhaled air.
Measured: 30 minutes at steady-state
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start29 Jan 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Associated Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246421
- Sponsor's protocol ID
- MASLD_GLUCA2025
- Other IDs
- 0092321
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms for Glucagon Resistance as Driver of Metabolic Associated Steatotic Liver Disease and Cardiovascular Disease in Humans With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07246421
- Acronym / sponsor ID
- MASLD_GLUCA2025
- Keywords
- MASLD, Glucagon, Glucagon Resistance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to investigate the sensitivity to glucagon in patients with type 2 diabetes mellitus (T2DM), with and without metabolic associated fatty liver disease (MASLD).
The main questions it aims to answer are:
- Is the sensitivity to glucagon with respect to hepatic FA oxidation and suppression of VLDL-TG secretion impaired in humans with T2DM and MASLD?
- Is glucagon resistance and MASLD reflected in an aberrated lipidomic/metabolomic profile in blood and adipose tissue?
Researchers will compare patients with T2DM with and without MASLD to see if the response to basal and high levels of glucagon differs between the groups.
Participants will attend 2 short visits and 1 full-day visit, including:
- Body scan (DXA) to check fat and bone composition
- MRI to measure liver fat.
- Blood tests.
- Ultrasound to check liver stiffness and scarring.
- Fat biopsies
- 8-hour hormone (including glucagon) and tracer infusion
- PET-CT scans
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with T2DM and MR spectroscopy verified NO steatosis | Active comparator | Other: Glugagon |
| Subjects with T2DM and MR spectroscopy verified steatosis | Active comparator | Other: Glugagon |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI > 26 kg/m²
- confirmed diagnosis of Type 2 Diabetes Mellitus (T2DM) min. 6 months prior enrollment
- steatosis FF% > 5,6% on MR spectroscopy for MAFLD group
Key exclusion criteria (16 listed)
- Alcohol abuse (>10 units per week for both sexes) or other substance abuse
- Smoking
- Current or previous malignant disease
- Blood donation within the last 3 months prior to the study day
- Participation in studies involving radioactive isotopes within the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlugagonInfusion of low dose glucagon and high dose glucagon during simultaneous somatostatin infusion and replacement doses of insulin and growth hormone. Infusion of palmitate, VLDL-triglyceride and glucose tracers. [11C]palmitate PET during low and high dose glucagon. | Other | Subjects with T2DM and MR spectroscopy verified NO steatosis, Subjects with T2DM and MR spectroscopy verified steatosis |
Primary outcome
Hepatic FFA oxidation rate (µmol/100Ml/min)
Time frame: 30 minutes at steady-state
Measured using [11C]palmitate positron-emission tomography (PET)
Blood and adipose tissue proteomic and lipidomic profiles
Time frame: 30 minutes after steady-state
Mass spectrometry-based lipidomic/proteomic profiles of paired adipose and plasma samples.
3 secondary outcomes
Endogen glucose production (mmol/kg/min)
Time frame: 30 minutes at steady-state
Fatty acid turnover (µmol/min)
Time frame: 30 minutesat steady-state
VLDL-triglyceride kinetics (appearance rate (µmol/min) and oxidation (µmol/min))
Time frame: 30 minutes at steady-state
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glugagon in people with Metabolic Associated Fatty Liver Disease and Type 2 Diabetes (T2DM), run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kia E. Fonfara, Medical Doctor (+4524607114, kia.eistrup@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic FFA oxidation rate (µmol/100Ml/min) (time frame: 30 minutes at steady-state). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.