Phase 1 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:

Single Dose Group (SAD cohorts):

• Women who cannot become pregnant, or men, aged 18 to 55 years old at the time of screening
• People with a body mass index (BMI) between 18.5 and 29.9 at screening (this is generally considered a "normal" to "overweight" range)
• People who are considered generally healthy based on their medical history, physical checks, heart trace, and blood test results, as assessed by the trial doctor

Multiple Dose Groups 1–3 (MAD1-3 cohorts):

• Women who cannot become pregnant, or men, aged 18 to 55 years old at the time of screening
• People with a BMI between 27.0 and 39.9 at screening, where the higher weight is due to excess body fat, as assessed by the trial doctor
• People considered eligible based on their medical history, physical checks, heart trace, and blood test results, as assessed by the trial doctor

Multiple Dose Group 4 (MAD4 cohort):

• Men aged 18 to 55 years old at the time of screening
• People with a BMI between 27.0 and 34.9 at screening, where the higher weight is due to excess body fat, as assessed by the trial doctor
• People who have been diagnosed with type 1 diabetes for at least one year before screening
• People who have been taking daily insulin injections (both a long-acting and a fast-acting insulin) for more than 90 days before screening
• People who have been using a continuous glucose monitoring (CGM) device for more than 90 days in a row before screening
• People whose HbA1c (a blood sugar average over roughly 3 months) is between 7.2% and 9.5% at screening

Who may not be able to join:

Single Dose Group (SAD cohorts):

• People with any condition, or who are unwilling or unable to follow the study requirements, that the trial doctor believes could affect their safety or ability to take part
• People whose HbA1c blood sugar level is 6.5% or higher at screening
• People who are unwilling or unable to stop taking prescription or over-the-counter medicines, herbal products, or non-routine vitamins in the 14 days before the first dose (note: occasional use of paracetamol or ibuprofen for pain is allowed up until 24 hours before dosing)

Multiple Dose Groups 1–3 (MAD1-3 cohorts):

• People with any condition, or who are unwilling or unable to follow the study requirements, that the trial doctor believes could affect their safety or ability to take part
• People with a current or past history of significant lung, metabolic, kidney, liver, heart, digestive system, or hormonal conditions
• People whose HbA1c is 6.5% or higher at screening
• People who are unwilling or unable to stop taking prescription or over-the-counter medicines, herbal products, or non-routine vitamins in the 14 days before the first dose (note: occasional use of paracetamol or ibuprofen for pain is allowed up until 24 hours before dosing)

Multiple Dose Group 4 (MAD4 cohort):

• People with any condition, or who are unwilling or unable to follow the study requirements, that the trial doctor believes could affect their safety or ability to take part (mild, stable conditions related to type 1 diabetes may be acceptable)
• People with a current or past history of significant lung, metabolic, kidney, liver, digestive system, or hormonal conditions — not including conditions directly related to diabetes or obesity
• People who have used any diabetes or obesity medication other than the insulin types listed in the inclusion criteria within 90 days before screening, or between screening and being assigned to a study group
• People currently being treated with certain medicines including systemic corticosteroids, MAO inhibitors, systemic non-selective beta-blockers, or growth hormone
• People who are expected to start or change medications known to affect weight or blood sugar (such as orlistat, thyroid hormones, or corticosteroids) for more than 14 days in a row during the trial
• People who are unwilling or unable to stop taking prescription or over-the-counter medicines, herbal products, or non-routine vitamins in the 14 days before the first dose (note: occasional use of paracetamol or ibuprofen for pain is allowed up until 24 hours before dosing)

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