Phase 4 Type 1 Diabetes Trial, Recruiting

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

Who might be able to join this trial:

• Adults (male or female) who have given written consent before any trial-related activities begin.
• People who have had a confirmed diagnosis of Type 1 diabetes (as defined by the American Diabetes Association 2024 criteria) for at least 1 year before the screening visit, with a very low C-peptide level (below 0.01 nmol/L), indicating little to no insulin production.
• People with a Body Mass Index (BMI) of 27.0 or higher (confirm with trial site for BMI calculation).
• People who have previously tried at least one diet or eating plan to lose weight without lasting success.
• People who have been using a Continuous Glucose Monitor (CGM) — a wearable device that tracks blood sugar levels — for at least 2 months before screening, and who are willing to keep wearing one throughout the entire study.

Who may not be able to join:

• People whose blood sugar control measurement (HbA1c) is at or above 10% (86 mmol/mol) at screening.
• People who have used a GLP-1 receptor agonist medication (a type of diabetes or weight-loss injection) within the 180 days before screening.
• People who have a moderate or advanced form of diabetic eye disease (called preproliferative or proliferative retinopathy).
• People who have experienced diabetic ketoacidosis (a serious diabetes complication) within the 6 months before screening.
• People who have had a severe low blood sugar episode requiring outside help (Level 3 hypoglycemia) within the 6 months before screening.
• People whose body weight has changed by more than 5 kg (11 lbs) in the 90 days before screening.
• People who have used any medication specifically prescribed for weight loss in the 90 days before screening.
• People who have previously had, or are planning to have during the trial, weight-loss surgery or a weight-loss device implanted (certain older procedures removed more than 1 year before screening may be allowed — confirm with trial site).
• People with an uncontrolled thyroid condition, based on a thyroid hormone level that is too high or too low at screening.
• People with a history of major depression within the 2 years before screening.
• People diagnosed with a severe psychiatric condition such as schizophrenia or bipolar disorder.
• People who score 15 or higher on a standard depression questionnaire (PHQ-9) at screening.
• People with any history of a suicide attempt at any point in their life.
• People who have shown suicidal behaviour in the 30 days before screening.
• People who have experienced certain types of suicidal thoughts (types 4 or 5 on a standard clinical scale) in the 30 days before screening.
• People who have used certain non-herbal traditional medicines with unspecified ingredients within the 90 days before screening.
• People who have had acute pancreatitis (sudden inflammation of the pancreas) within the 180 days before screening.
• People with a history or current diagnosis of chronic pancreatitis (long-term pancreas inflammation).
• People with a calcitonin level (a hormone marker measured in the blood) at or above 100 ng/L at screening.
• People who, or whose close blood relatives, have a personal history of a condition called Multiple Endocrine Neoplasia type 2 or medullary thyroid carcinoma (a type of thyroid cancer).
• People with severely reduced kidney function, based on a specific kidney test result at screening (confirm with trial site).
• People who have been diagnosed with cancer (other than certain types of non-invasive skin cancer) within the 5 years before screening.
• People who have had a heart attack, stroke, hospitalisation for chest pain (unstable angina), or a mini-stroke (TIA) within the 60 days before screening.
• People classified as having the most severe level of heart failure (New York Heart Association Class IV).
• People who have planned surgery during the trial period, unless the trial doctor considers the procedure minor.
• People with known or suspected alcohol or recreational drug misuse.
• People with a known or suspected allergy or sensitivity to the trial medication or related products.
• People who have previously signed consent to participate in this same trial.
• People who have taken part in another clinical trial within the 90 days before screening.
• People living in the same household as someone already participating in any trial involving the medication semaglutide.
• People who are pregnant, breastfeeding, planning to become pregnant, or who are able to become pregnant and are not using a highly effective form of contraception.
• People who have any other condition, concern, or circumstance that the trial doctor believes could affect their safety or ability to follow the trial requirements.

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