Recruiting
Phase 2

Liraglutide

Sponsor:

Mansa

Code:

NCT07029009

Conditions

Maturity Onset Diabetes of the Young

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

Interventions

Liraglutide

Study Details

Brief summary:

The reason for this research study is to better understand the use of liraglutide, a commonly prescribed Type 2 diabetes medication, in patients with a diagnosis of maturity-onset diabetes of the young (MODY).

The investigators are interested in better understanding the way that this drug affects the metabolism and hormone levels of a person with MODY. Many people with MODY report having gastrointestinal (GI) issues such as an upset stomach. Investigators also are interested in finding out if this drug will help with GI issues.

If liraglutide does help with this symptom of MODY, the investigators want to know why this happens. If this drug is effective for participants, the investigators will use participants cells to make human induced pluripotent stem cell (iPSC). This means that the investigators will use participant cells to create what are called stem cells, which are cells in the body that are able to be told what their job is. Investigators will use these cells to see what happens in gastrointestinal (GI) tract.

Conditions

Maturity Onset Diabetes of the Young

Study ID

NCT07029009

Start date

May 8, 2025

Status verified date

Dec, 2024

Completion date

Jan, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: liraglutide treatment

After baseline evaluation of enteroendocrine levels and metabolism, study participants will be prescribed liraglutide. Titration of liraglutide will be as follows: 1) Starting dose of liraglutide 0.6 mg daily for 1 week, 2) Increase to liraglutide 1.2 mg daily for 1 week, and 3) Maintain at final dose of liraglutide 1.8 mg daily. If study participants are unable to tolerate liragultide 1.8 mg daily due to side effects for 1 week, then will decrease back to liraglutide 1.2 mg daily.

Interventions

Liraglutide

Liraglutide will be prescribed following FDA approved packet insert for type 2 diabetes in our test population.

Primary outcome measure

  • Blood sugar control - HbA1C [ Time Frame: Baseline and 3 months after study treatment initiation ]
  • BMI [ Time Frame: baseline, 1 month, 2 months, and final study visit 3 months after study treatment initiation ]

Central Contacts and Locations

Central contacts

Mansa Krishnamurthy, M.D.

513-636-4744mansa.krishnamurthy@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Lily Deng

513-636-0002lily.deng@cchmc.org

Principal Investigator:

Mansa Krishnamurthy

More Information

Sponsor

Mansa

Last update posted

Dec 17, 2025

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mansa on 2025-12-17.