The two studies aim to compare the effects of an investigational study drug, at several different doses, on reducing body weight over 36 weeks. The studies will also check what side effects people experience, and whether they are manageable. In both ACCESS and ACCESS II, the study drug will be compared to placebo.
In either study, a computer will choose at random whether you receive the study drug or placebo. You will not be able to choose nor will you know whether you are receiving study drug or placebo.
- In the ACCESS Study, for every 3 people that receive the study drug, 1 person will receive placebo.
- In the ACCESS II Study, in the first group of participants, for every 4 that receive the study drug, 1 will receive placebo. In the rest of the participants, for every 5 that receive the study drug, 1 will receive placebo.
A placebo looks like the study drug but does not contain any medically active ingredients. Study drugs are frequently compared to placebo. This helps study investigators find out which outcomes that people experience are related to the study drug rather than any other part of being in the clinical study.
Both the study drug and the placebo are tablets taken by mouth once daily.
All drugs, whether approved or investigational, can cause unwanted side effects. You may have side effects from taking the study drug or from the procedures and assessments that are part of the study. However, you will be closely monitored throughout your participation for any side effects, and a study team will be there to support you.
You will receive nutrition and physical activity advice throughout your participation. If the study doctor finds that your mental health is changing during the study, you may be referred to a mental health professional, as needed.
The total time you will be in the study is around 41 weeks. This includes up to 4 weeks of Screening time, 36 weeks of study treatment, and 1 week of follow-up. This is the same whether you take part in ACCESS or ACCESS II.
Initially you would attend a Screening visit to check whether one of the studies is a good fit for you. A study doctor will let you know which study you will potentially join. No health checks or assessments will take place until you have received and understood all study-related information, and you have given your voluntary consent to participate.
If you are enrolled, as part of the commitments for either study you will:
- Take your assigned study treatment (study drug or placebo) once daily each day for around 36 weeks.
- Fill in a diary to record your study treatment dosing and any potential side effects.
- Visit the study center around every 4 weeks for health assessments.