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Study of semaglutide for weight loss in adults with type 1 diabetes and obesity

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people who have both Type 1 Diabetes and obesity. The research aims to examine how well a medication called semaglutide works for reducing body weight in people with these conditions. Semaglutide is a medication that is already approved and used to help control blood sugar levels. It belongs to a group of medications called GLP1-receptor agonists.

During the study, participants will receive either semaglutide or placebo as a subcutaneous injection (an injection under the skin). The treatment will continue for 68 weeks. The medication dose will be gradually increased over time, reaching a maximum daily dose of 2.4 mg.

The study will measure various health indicators including body weight, blood pressure, blood sugar control, and other health markers. Some participants will also undergo additional tests to measure body composition and insulin sensitivity. Throughout the study, participants will need to continue their regular diabetes care and insulin treatment while receiving the study medication.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial Treatment Phase

    You will be randomly assigned to receive either semaglutide or placebo through subcutaneous injection (injection under the skin)

    Your initial health measurements will be recorded, including body weight, blood pressure, heart rate, and waist measurements

    Blood samples will be collected to check various health indicators

  2. Step 2

    Regular Health Monitoring

    Your blood sugar levels will be monitored using a continuous glucose monitoring (CGM) device

    You will need to report your daily insulin usage

    Regular blood tests will check your: blood sugar control, kidney function, liver function, and cholesterol levels

  3. Step 3

    Additional Assessments

    You will undergo an electrocardiogram (ECG) to monitor heart activity

    You will complete questionnaires about your eating habits and diabetes management experience

    Some participants may be selected for additional tests including body composition scans and tissue samples

  4. Step 4

    Study Duration

    The study will run from October 2025 to June 2028

    Regular follow-up visits will be scheduled throughout the study period to monitor your progress and health status

Who can join the trial?

12 criteria

  • Must be diagnosed with Type 1 Diabetes for at least 3 years
  • Must be 18 years or older
  • Must have obesity defined by one of these conditions:
    • A BMI of 30 or higher (BMI is a measure of body fat based on height and weight)
    • A BMI of 27 or higher plus at least one obesity-related condition such as:
      • High blood pressure (hypertension)
      • High cholesterol (hypercholesterolemia)
      • Abnormal blood fat levels (dyslipidemia)
      • Protein in urine (micro albuminuria)
      • Heart disease
      • Previous stroke
      • Hardening of arteries (atherosclerosis)
      • Joint disease (arthrosis)
      • Both men and women can participate

Who cannot join the trial?

15 criteria

  • History of pancreatitis (inflammation of the pancreas)
  • Multiple endocrine neoplasia syndrome type 2 (a rare inherited condition affecting hormone-producing glands)
  • Personal or family history of medullary thyroid cancer (a rare type of thyroid cancer)
  • Pregnancy or breastfeeding
  • Severe kidney disease (kidney function significantly reduced)
  • Uncontrolled diabetic retinopathy (damage to the blood vessels in the eye caused by diabetes)
  • History of gastroparesis (delayed stomach emptying)
  • Major cardiovascular events in the past 6 months (such as heart attack or stroke)
  • Current treatment with other weight loss medications
  • History of eating disorders
  • Substance abuse within the past year
  • Mental health conditions that are not well controlled
  • Planned major surgery during the study period
  • Participation in another clinical trial within the past 30 days
  • Known allergic reactions to the study medication or its components
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Investigated drugs

Semaglutide is a medication that belongs to a class of drugs called GLP-1 receptor agonists. It helps control blood sugar levels and can reduce appetite, which leads to weight loss. In this trial, it's being studied specifically for people who have both type 1 diabetes and obesity. The medication is typically given as an injection under the skin and works by mimicking a natural hormone that helps regulate hunger and food intake.

What is already known about the treatment

Semaglutide - A prescription medication administered as a subcutaneous injection, belonging to the GLP-1 receptor agonist class of drugs, which has gained significant recognition in modern diabetes and obesity treatment. This medication works by mimicking the effects of the natural hormone GLP-1, helping to regulate blood sugar levels by stimulating insulin production when blood glucose is high, while also reducing appetite through its effects on brain centers controlling hunger and satiety. Semaglutide has been proven effective in treating both type 1 diabetes and obesity, particularly in patients with a BMI of 27 or higher, and has shown promising results in addressing obesity-related complications such as hypertension and dyslipidemia. The medication's once-weekly dosing schedule makes it a convenient option for long-term treatment, while its dual action on blood sugar control and weight management has made it a valuable tool in modern metabolic medicine.

Investigated diseases

  • Type 1 Diabetes

    A chronic condition where the pancreas produces little or no insulin, which is a hormone needed to allow sugar to enter cells to produce energy. The immune system attacks and destroys insulin-producing cells in the pancreas. This results in increased blood sugar levels in the body. The condition typically develops during childhood or adolescence, though it can occur at any age.

  • Obesity

    A complex medical condition characterized by excessive accumulation of body fat. It is measured by Body Mass Index (BMI), with values of 30 or higher indicating obesity, while values of 27 or higher with related health conditions are considered clinically significant. The condition develops gradually through an imbalance between calorie intake and energy expenditure. The excess weight puts additional stress on various body systems and can affect overall physical function.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522326-13-00Estimated enrolment122 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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