Health Awareness Inc | Jupiter, FL
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
This study is open to adults who are at least 18 years old and have
People with a history of other chronic liver diseases cannot take part in this study.
The purpose of this study is to find out whether a medicine called survodutide helps people living with obesity or overweight and a confirmed or presumed liver disease called nonalcoholic steatohepatitis (NASH) to have less liver fat and to lose weight. Participants are put into 2 groups randomly, which means by chance. 1 group gets different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week for about 1 year. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for about 1 year and 3 months. During this time, it is planned that participants visit the study site up to 13 times and receive 3 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At 3 of the visits, the participants' liver is measured using different imaging methods. The results are compared between the groups to see whether the treatment works.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key inclusion criteria:
Age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
BMI ≥30 kg/m², OR BMI ≥27 kg/m² and at least one of the following weight-related comorbidities at screening:
History of at least one self-reported unsuccessful dietary effort to lose body weight Further inclusion criteria apply.
Key exclusion criteria:
Further exclusion criteria apply.
Primary purpose
Allocation
Interventional model
Masking
160 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
Boehringer Ingelheim
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal