*Terms & Conditions apply.
Study Information
Simbec-Orion Clinical Pharmacology are running a first-in-human study to investigate a new potential medicine. The primary objectives of this study are to determine the safety and tolerability of the drug when it is administered as a single dose at different dose strengths on one occasion in Part A and on two occasions in Part B to participants who are overweight or living with obesity. This study is now actively recruiting for Part B of the study.
This study will be split into two groups: those overweight or obese, diagnosed/undiagnosed with pre-Type 2 Diabetes and those overweight or obese, diagnosed with Type 2 Diabetes.
Sentinel Cohort Dosing Group
A minimum of 1 screening visits must be completed within 35 days of dosing. If you participate in a sentinel cohort group, you will be required to stay at the Simbec-Orion clinical unit for a maximum of 6 overnight stays, for the in-house stay requirements. The total number of overnight stays will be dependent on which sentinel cohort group you screen or wish to participate.
In addition to the overnight stays listed above, there will be a two scheduled telephone calls and a maximum of 30 return visits over the period of 11 months, again the total number of return visits will be dependent on which sentinel cohort group you screen or wish to participate.
If you participate in this study, you will receive an inconvenience payment for the inconvenience of participating in and satisfactorily completing the study including all procedures and the post-trial follow up visit, along with the highest level of compliance.
The payment will be also split across the study, and you will receive set payments following completion of certain visits throughout the study. The maximum reimbursement and inconvenience payment for participating in this group/cohort is £9625.
Non- Sentinel Cohort Dosing Group
A minimum of 1 screening visits must be completed within 35 days of dosing. If you participate in a sentinel cohort group, you will be required to stay at the Simbec-Orion clinical unit for a maximum of 4 overnight stays, for the in-house stay requirements. The total number of overnight stays will be dependent on which sentinel cohort group you screen or wish to participate.
In addition to the overnight stays listed above, there will be a two scheduled telephone calls and a maximum of 32 return visits over the period of 11 months, again the total number of return visits will be dependent on which non- sentinel cohort group you screen or wish to participate.
If you participate in this study, you will receive an inconvenience payment for the inconvenience of participating in and satisfactorily completing the study including all procedures and the post-trial follow up visit, along with the highest level of compliance.
The payment will be also split across the study, and you will receive set payments following completion of certain visits throughout the study. The maximum reimbursement and inconvenience payment for participating in this group/cohort is £8825.
