Phase 2 Type 2 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:

• Adults aged 18 to 65 years old (inclusive)
• People with a body mass index (a measure of body weight relative to height) between 18 and 35
• People with normal blood pressure or high blood pressure that is well controlled (below certain measured levels)
• People who have had a confirmed diagnosis of type 2 diabetes for at least 1 year, based on repeated lab results
• People who are managing their type 2 diabetes either with a stable dose of the medication metformin (up to 2g daily for at least 2 months before joining) or through diet and exercise alone
• People whose blood sugar levels have been stable for at least 2 months before joining, and who agree not to change their diabetes management until a specific point in the study
• People with a fasting blood sugar level of 5.6 mmol/L or above at the initial screening visit
• People with an HbA1c (a measure of average blood sugar over time) between 6.5% and 9.0% at screening
• People with heart rate and blood pressure readings within specific ranges after resting for 10 minutes (confirm with trial site for exact values)
• People with a normal heart electrical activity reading (ECG) within specific ranges at screening
• People with no significant heart or other major illness in the past 3 years, other than type 2 diabetes and well-managed high blood pressure (exceptions may be considered by the trial doctor)
• People who test negative for certain drugs of abuse at screening and at admission (alcohol is also tested at admission)
• Women who are not pregnant, not breastfeeding, and who are either surgically unable to become pregnant, post-menopausal for at least 12 months, abstinent from heterosexual intercourse, or using a highly effective form of contraception from screening until the study ends
• Women who are capable of becoming pregnant must have a negative pregnancy test at screening and admission, and agree to additional pregnancy tests during the study
• Men who are surgically sterile, abstinent, or who agree (along with their partner) to use effective contraception from screening until the study ends, and who agree not to donate sperm during that time

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant within 30 days after the last dose of the study drug
• People who have taken part in another clinical trial within the past 30 days, or who have recently used an experimental treatment (timeframes vary depending on the type of treatment — confirm with trial site)
• People who have received any vaccine (other than the current seasonal flu vaccine) within 2 weeks before the first dose or until 2 weeks after the last dose
• People who have used any weight loss medication or product in the past 4 weeks
• People who have had surgery or been hospitalised in the 4 weeks before screening
• People who have a planned procedure or surgery during the study period
• People who have had a blood transfusion within the past 8 weeks
• People who have donated or lost 300mL or more of blood within 30 days before the study drug is first given
• People with poor vein access that makes blood draws difficult
• People with a history of alcohol or substance misuse or dependence in the past 2 years
• People with unstable or significant heart disease in the past 2 years (such as a heart attack or significant heart failure)
• People with a history of pancreatitis (inflammation of the pancreas)
• People with a significant or abnormal heart electrical activity reading (ECG), or evidence of a heart attack within the past 2 years
• People with a history of certain irregular heart rhythms, structural or coronary heart disease, significant abnormalities in certain blood mineral levels, or a family history of sudden unexplained death or a condition called long QT syndrome
• People with impaired liver function based on certain blood test results at screening
• People with an unstable thyroid condition (overactive or underactive)
• People with a personal or family history of a specific type of thyroid cancer (medullary thyroid cancer) or a condition called multiple endocrine neoplasia syndrome Type 2
• People with a current or past history of bulimia or anorexia nervosa
• People with a history of severe allergic reactions (requiring hospital care) or known allergies to the study drug or its components
• People diagnosed with Type 1 diabetes or who have previously had diabetic ketoacidosis (a serious diabetes complication)
• People with a history of or ongoing inflammatory bowel disease or diabetic gastroparesis (a condition affecting stomach emptying)
• People who have had a severe low blood sugar episode (causing seizure, unconsciousness, coma, or hospitalisation) in the past 3 months
• People whose blood sugar levels are not controlled by metformin, diet, or exercise
• People with significant diabetic eye disease, kidney-related diabetes complications, or reduced kidney function (as assessed by the trial doctor)
• People with any other serious medical condition or abnormal lab results that the trial doctor believes would make participation unsafe or interfere with the study
• People using any diabetes medication other than metformin at or between screening and the start of the study
• People taking any other medication in the 14 days before the first dose, unless specifically permitted by the trial doctor
• People who have used certain diabetes medications — including DPP-4 inhibitors, GLP-1 agonists, SGLT-2 inhibitors, insulin, thiazolidinediones, or acarbose — in the 3 months before joining (confirm with trial site for specific drug names)
• People who are unwilling or unable to follow the study requirements

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