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)
Maturity-onset diabetes of the young (MODY) is a rare, genetic form of diabetes that runs in families. People with HNF1A-MODY or HNF4A-MODY are usually treated with tablets called sulfonylureas. However, keeping blood sugar levels steady without causing sudden drops (hypos) can still be tricky. This trial is testing whether adding semaglutide—a medicine commonly used for type 2 diabetes—can help people with MODY manage their blood sugar more effectively. Semaglutide works by helping the pancreas release insulin when food is eaten and by curbing appetite. Participants will receive either semaglutide injections or a dummy injection (placebo) alongside their regular diabetes tablets. Doctors will track blood glucose using continuous wearable monitors to see if the medicine keeps blood sugar in a safe, healthy range and whether it helps with overall health and weight.
At a glance
What is this study about?
Maturity-onset diabetes of the young, often shortened to MODY, is different from type 1 and type 2 diabetes. It is caused by a change in a single gene that is passed down through families. People with the HNF1A and HNF4A types of MODY usually produce some insulin of their own and typically take tablets called sulfonylureas to help their pancreas work better. Over time, however, these tablets may not be enough on their own, or they can sometimes cause blood sugar levels to drop too low.
Semaglutide is an approved medicine that mimics a natural gut hormone to help control blood sugar and support weight management in type 2 diabetes. Because it works in a gentle, food-dependent way, researchers believe it might also be a valuable extra treatment for people with these specific types of MODY. This study aims to find out if combining semaglutide with regular sulfonylurea tablets provides better, smoother blood sugar control.
To find out, researchers are running a Phase II exploratory study. Participants will wear a small continuous glucose monitor (CGM) on their skin, which automatically reads sugar levels day and night. By comparing blood readings between those taking semaglutide and those taking an inactive dummy treatment (placebo), doctors hope to discover new and safer treatment options for families living with MODY.
Key takeaways
- Tests whether adding weekly semaglutide to standard tablets helps control blood sugar in HNF1A- and HNF4A-MODY.
- Open to adults aged 18 and over with a confirmed genetic diagnosis of MODY type 1 or type 3.
- Involves wearing a continuous glucose monitor (CGM) to track sugar levels day and night.
- Compares the active medicine against a dummy injection (placebo) to ensure fair results.
- Participation is entirely voluntary and will not affect your standard NHS diabetes care.
Who may be eligible?
This trial is open to men and women aged 18 and older who have been diagnosed with either HNF1A-MODY (type 3) or HNF4A-MODY (type 1). To take part, you must currently be taking a sulfonylurea tablet (such as gliclazide) to manage your blood sugar.
You may not be eligible if you have certain other medical conditions, such as severe kidney or liver problems, a personal history of pancreatitis, or if you are pregnant, planning a pregnancy, or breastfeeding.
Your diabetes doctor or the trial team can confirm your specific genetic diagnosis and review your current medications to let you know safely if this study is an option for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am 18 years of age or older.
- I have a confirmed genetic diagnosis of HNF1A-MODY (type 3) or HNF4A-MODY (type 1).
- I am currently taking a sulfonylurea tablet (such as gliclazide or glimepiride) for my diabetes.
- I am comfortable using a small, weekly self-injection pen under guidance.
- I am not pregnant, planning to become pregnant during the study, or breastfeeding.
What does participation involve?
Taking part involves several visits to a hospital or clinical research centre over a set study period. During the trial, you will be shown how to give yourself a simple, small injection under the skin once a week. You will receive either semaglutide or a matching placebo injection, alongside your usual diabetes tablets.
You will wear a small, painless glucose sensor on your arm or tummy (a continuous glucose monitor) for designated periods, particularly during the final weeks of each treatment stage. At clinic visits, the team will check your blood pressure, measure your waist and body composition, take routine blood samples, and ask you about any symptoms or low blood sugar episodes. The study team will support you throughout the trial and monitor your health closely.
Potential risks and benefits
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Common questions
What is MODY?
MODY stands for Maturity-Onset Diabetes of the Young. It is a rare type of diabetes caused by a change in a single gene, meaning it often runs directly in families.
What is a placebo?
A placebo is a dummy treatment that looks and is used just like the real medicine, but contains no active drug. It helps researchers prove whether the real medicine genuinely works.
Will I have to stop taking my regular diabetes tablets?
No. In this trial, the study treatment is designed as an 'add-on', meaning it is taken alongside your regular sulfonylurea tablets.
Is semaglutide the same as insulin?
No. Semaglutide is not insulin. It is a medicine that helps your pancreas release its own natural insulin only when your blood sugar rises after eating.
What happens if I change my mind during the study?
You can leave the study at any point. You do not need to give a reason, and choosing to withdraw will never affect your day-to-day medical treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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