2025-523414-89-00Not yet recruitingPhase 2
Effects of semaglutide as add-on therapy to sulfonylurea on plasma glucose in individuals with HNF1A- and HNF4A-MODY – A Steno MODERN-MODY project (MM-SEMA)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 8 Sept 2026
Brief summary (registry, in English)
To investigate the glucose-lowering effect of once-weekly administered semaglutide (0.25-0.5 mg) in individuals with HNF1A- and HNF4A-MODY.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 5 Jun 2026
- Start date
- 1 Sept 2026
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Diseases
- Type 1 diabetes
- EU CT number
- 2025-523414-89-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 54
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with diabetes caused by an HNF1A or HNF4A gene change (MODY) who take a sulfonylurea. It tests once-weekly semaglutide.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Diabetes caused by an HNF1A or HNF4A gene change, with HbA1c of 48 mmol/mol or higher, or insulin treatment in the past 90 days.
- Earlier treatment
- Must have taken a sulfonylurea in the past 90 days. Cannot have had a GLP-1RA in the past 60 days, or a DPP-4 inhibitor or SGLT2 inhibitor in the past 30 days.
- Biomarker or test result
- A heterozygous pathogenic or likely pathogenic variant in HNF1A or HNF4A (by ACMG criteria).
Main reasons for not taking part
- Pregnant, breastfeeding, planning pregnancy, or not using adequate contraception
- History of acute or chronic pancreatitis
- End-stage liver disease
- eGFR below 15 ml/min/1.73m2
- Treatment for proliferative retinopathy within 90 days before screening
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous randomisation in this trial
- Treatment for proliferative retinopathy within 90 days prior to screening
- Treatment with GLP-1RA within 60 days prior to screening
- Treatment with DPP-4 inhibitor or SGLT2 inhibitor within 30 days prior to screening
Other illness
- History of acute and/or chronic pancreatitis
- End-stage liver disease
- Known or suspected allergy to trial medication(s), excipients, or related products
Lab values
- eGFR <15 ml/min/1.73m2
- Inability (judged by investigator) or unwillingness (of the potential participant) to abstain from a variable dosing regimen of glucose-lowering drugs (i.e., SU, repaglinide or insulin (prandial insulin) in a self-titrated regimen) during the study
Other
- Pregnant, breastfeeding, or the intention of becoming pregnant or not using adequate contraceptive measures
Who the study is looking for
- Ability to provide informed consent before any trial-related activities
- Diabetes caused by a heterozygous pathogenic or likely pathogenic variant in HNF1A or HNF4A (according to ACMG criteria)
- Age ≥18 years
- HbA1c ≥48 mmol/mol OR treatment with insulin in the preceding 90 days
- Treatment with sulfonylurea in the preceding 90 days
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital | Aarhus | Denmark | Not yet recruiting |
| Steno Diabetes Center Copenhagen | Herlev | Denmark | Not yet recruiting |
| Odense University Hospital | Odense | Denmark | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.