Phase 2 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:

• People who are willing and able to sign a consent form agreeing to take part in the study
• People who are able to attend and follow all study requirements for the full duration of the trial
• People who have had type 1 diabetes for at least one year
• People aged 18 to 45 years
• People whose HbA1c blood sugar average result is below 10%
• People with a body mass index (BMI) between 18 and 35, and who also either have a BMI of 25 or above, or use a daily insulin dose of 0.5 units or more per kilogram of body weight
• People who are currently using a closed-loop automated insulin delivery (AID) system that works with the Dexcom G7 continuous glucose monitor (CGM)
• People who have been on a stable dose of any non-diabetes medications for the last 6 months
• People whose blood test results at screening are within normal ranges or show nothing of medical concern
• People who are able to swallow oral medication and are willing to take the study drug or placebo for 12 weeks
• People of reproductive potential who agree to use adequate contraception during the study and for 2 weeks after the study drug period ends
• Males of reproductive potential who agree to use condoms or other effective contraception with their partner during the study
• People who agree to follow the lifestyle guidelines set out for the study duration

Who may not be able to join:

• People who are currently pregnant or breastfeeding
• People who have smoked tobacco products at any point in the last two years
• People with a history of alcohol misuse or illicit drug use within 6 months before screening
• People with a known diagnosis of HIV
• People with a history of significant other medical conditions — such as heart, stroke, gastrointestinal, liver, kidney, or hormonal disorders — that the study doctor considers could affect the results
• People who have had major surgery on their digestive tract (such as gastric bypass, stomach stapling, bowel removal, or similar procedures), or who currently have active inflammatory bowel disease, as these may affect how the study drug is absorbed
• People who currently take any blood sugar-lowering medication other than insulin (for example, GLP-1 receptor agonists or SGLT-2 inhibitors)
• People who have had a dose change in blood pressure or cardiovascular medications (such as beta-blockers, statins, or diuretics) within the last 4 months
• People who use anti-inflammatory medications (such as ibuprofen, aspirin, or steroid tablets) on a daily basis
• People who have been diagnosed with peripheral neuropathy (nerve damage, assessed by a foot sensitivity test at screening)
• People whose urine test shows high levels of a protein called albumin, above a certain threshold, which can indicate kidney stress
• People with more than mild, early-stage diabetic eye disease (retinopathy)
• People who have had a severe hypoglycaemic (very low blood sugar) episode requiring outside assistance within the last 12 months
• People who have had diabetic ketoacidosis (DKA) within the last 12 months
• People whose heart trace (ECG) at screening shows signs of irregular heartbeat, heart node disease, or reduced blood flow to the heart
• People whose blood oxygen level at screening is below 90%
• People with a known allergy or previous bad reaction to the study drug or closely related substances
• People taking certain other medications that are broken down by specific liver enzymes (CYP2C8 or CYP2C), including paclitaxel, phenytoin, warfarin, celecoxib, tolbutamide, or repaglinide, during the study period
• People who have participated in another clinical drug trial, or received an experimental drug, within 30 days (or 5 half-lives of that drug, whichever is longer) before the start of this trial

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