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Tests semaglutide with a sulfonylurea in people with HNF1A- or HNF4A-MODY diabetes

Tests once-weekly semaglutide added to sulfonylurea in adults with HNF1A or HNF4A MODY diabetes.

Key facts

Who runs it
Steno Diabetes Center Copenhagen
Where
Aarhus, Herlev, and Odense, DenmarkSee the 3 sites
Trial code
Registry title
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)
Status
Not yet recruiting
Phase
Phase 2
People taking part
54 people, planned
Started
1 Sept 2026
Expected to end
4 Aug 2028
Type of study
Interventional
Record updated
8 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. 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 (6.5%) 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

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • History of acute and/or chronic pancreatitis
  • End-stage liver disease
  • Known or suspected allergy to trial medication(s), excipients, or related products
  • 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
  • Pregnant, breastfeeding, or the intention of becoming pregnant or not using adequate contraceptive measures

Where in Denmark

  • Aarhus University HospitalAarhus, DenmarkNot yet recruiting
  • Steno Diabetes Center CopenhagenHerlev, DenmarkNot yet recruiting
  • Odense University HospitalOdense, DenmarkNot yet recruiting

About the trial

What the trial wants to find out

To investigate the glucose-lowering effect of once-weekly administered semaglutide (0.25-0.5 mg) in individuals with HNF1A- and HNF4A-MODY.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Tests semaglutide with a sulfonylurea in people with HNF1A- or HNF4A-MODY diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
8 September 2026