Phase 2 Type 1 Diabetes Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 30 years old who have been diagnosed with Type 1 diabetes (T1D).
• People whose diabetes was diagnosed at least 12 months ago.
• People whose body mass index (BMI) is 30 or higher, or whose BMI is 27 or higher along with a health condition related to their weight.
• People whose HbA1c (a measure of average blood sugar over roughly 3 months) was 10% or below at screening and within the past 90 days.
• People whose insulin doses have stayed roughly the same (within 15%) over the past 90 days.
• People whose BMI has stayed roughly the same (within 5%) over the past 90 days.
• People who are currently using a real-time continuous glucose monitor and plan to keep using one throughout the trial.
• People who are able to give written consent before any trial-related activities take place.
• People who are willing and able to follow all study procedures and attend all required visits for the full duration of the study.
• People of childbearing potential who are willing to use a highly effective form of contraception starting at least 1 month before joining the trial, throughout the study, and for 2 months after the last dose of study medication. Accepted methods include combined oral or hormonal contraception, progestogen-only contraception, an intrauterine device or system, bilateral tubal occlusion, a vasectomised partner (with documentation), or complete abstinence from male-female sexual activity.
• People whose blood test results at screening fall within the following ranges: creatinine below 1.0 mg, triglycerides below 400 mg/dL, and liver enzyme ALT below 3.5 times the upper normal limit.

Who may not be able to join:

• People who are currently using, or have used in the past 6 months, any additional diabetes medications (beyond insulin) or weight-loss medications, including any GLP-1 medications.
• People whose daily insulin dose is less than 0.5 units per kilogram of body weight per day.
• People with current psychiatric conditions that affect weight, including known eating disorders.
• People with a personal history of pancreas inflammation (pancreatitis), kidney problems, or liver disease other than a specific type of fatty liver condition.
• People with a personal or family history of a specific type of thyroid cancer (medullary thyroid cancer) or a condition called Multiple Endocrine Neoplasia Type 2.
• People with a known or suspected allergy to semaglutide (the study drug) or related products.
• People taking cholesterol-lowering medications other than statins or omega-3 products.
• People who have already been randomised (formally assigned to a treatment group) in this trial previously.
• People who are pregnant, breastfeeding, planning to become pregnant, or not using adequate contraception.
• People who have had diabetic ketoacidosis (a serious diabetes complication) in the past 6 months.
• People who do not meet MRI safety requirements, or who have claustrophobia that would prevent them from having an MRI scan.
• People with anaemia or a blood condition that affects HbA1c readings, or another medical condition that would prevent safe participation.
• People who have taken part in another clinical trial or received another investigational treatment within the past month.
• People who score above 15 on a standard depression questionnaire (PHQ-9), have a lifetime history of suicide attempts, or have had suicidal thoughts within the past 3 months (as assessed by a standard scale called the C-SSRS).
• People with a corn allergy.
• People who have had a severe low blood sugar episode requiring hospitalisation in the past 3 months.
• People with a significant condition affecting stomach emptying (clinically significant gastroparesis).

Important: Always verify eligibility with the trial site directly before applying.