Liraglutide for people with maturity-onset diabetes of the young (MODY)
Official title: Investigating Enteroendocrine Dysfunction, Metabolism, and Response to Liraglutide in Patients With Maturity-onset Diabetes of the Young (MODY)
Run by Children's Hospital Medical Center, Cincinnati · NCT07029009 · Data updated 2026-11-12
This trial will try liraglutide in people with genetically confirmed MODY to see if it improves blood sugar, body weight, and gastrointestinal symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 10 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Status | Recruiting |
| Started | May 8, 2025 |
| Main results expected | August 2026 |
| Study ends | January 2027 |
| Registry record updated | December 17, 2025 |
| Trial ID | NCT07029009 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People with a genetic diagnosis of MODY and HbA1c between 6.5% and 10% who are not already taking GLP‑1 receptor agonists and who do not have contraindications such as recent DKA, pancreatitis, active kidney disease, pregnancy, prior bariatric surgery, very low BMI, or family/personal history of medullary thyroid cancer would be ideal candidates.
✕Probably not a fit
Patients already using GLP‑1 receptor agonists, those with HbA1c over 10% or recent DKA, active kidney disease, prior pancreatitis, relevant cancer risk, recent bariatric surgery, pregnancy, or very low BMI are unlikely to be eligible or to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants with genetically confirmed MODY will undergo baseline metabolic, hormonal, and imaging evaluations before starting liraglutide. Investigators will initiate liraglutide and repeat labs and imaging to measure changes in HbA1c, BMI, enteroendocrine biomarkers, and GI symptoms. Up to about 50 participants will be enrolled, and a subset will consent to provide cells for generation of human induced pluripotent stem cells (iPSC) to study cellular mechanisms of enteroendocrine dysfunction. The study tests the hypothesis that heterozygous MODY gene variants contribute to GI and enteroendocrine abnormalities that may respond to GLP‑1 receptor agonist therapy.
Why it matters
Potential benefit: If successful, liraglutide could offer people with MODY better glucose control, possible weight benefit, and relief of gastrointestinal symptoms.
How similar studies have gone: GLP‑1 receptor agonists are proven to improve glycemia and reduce weight in type 2 diabetes, but their use specifically in MODY has limited evidence and is largely supported by small case reports and emerging data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of MODY via genetic testing * HgbA1c \>6.5% Exclusion Criteria: * History of anaphylaxis to GLP-1 receptor agonists * Already taking GLP-1 receptor agonists * on medications within the stimulant class * have had bariatric surgery * personal or family history of cancer, especially medullary thyroid cancer * personal history of pancreatitis or pathogenic variants associated with increased risk of pancreatitis * known active kidney disease * severe hypoglycemia (glucose \< 50 mg/dL) within 3 months of study enrollment * HbA1c \> 10.0% * episode of diabetic ketoacidosis (DKA) in the past 3 months * are currently pregnant * BMI \< 18.5 kg/m2 and pediatric patients with BMI \< 5th percentile
Where it's running
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States Recruiting
Study contacts
- Principal investigator: Mansa Krishnamurthy, M.D. — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Mansa Krishnamurthy, M.D.
- Email: mansa.krishnamurthy@cchmc.org
- Phone: 513-636-4744
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Chinese monogenic diabetes registry
This project will test whether an online and mobile registry can find and genetically confirm people in China with monogenic forms of diabetes, including neonatal diabetes and MODY.
-
Registry for young-onset diabetes and its genetic factors
This study is creating a registry for young people with diabetes to see how different types of the condition, especially MODY, affect their health and treatment options.
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Identifying Monogenic Diabetes Misdiagnosed as Type 1
This study is trying to find out how often young people are wrongly diagnosed with type 1 diabetes when they actually have a rare form called monogenic diabetes, by testing their blood and looking for specific genetic changes.
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Reducing high insulin levels to improve heart and blood sugar health in type 1 diabetes
This study is testing whether a new medication can help people with type 1 diabetes lower their insulin levels to improve their heart and blood sugar health.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.