Study Details

Open

Study for patients who are overweight or obese with heart disease or chronic kidney disease

In this study, we want to learn more about an investigational drug (BI 456906) for patients who are overweight or obese and have heart disease or kidney disease. We will compare this drug to a placebo when used as an addition to the standard of care. This will help us to learn if the drug is effective in reducing cardiovascular risks.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

At in-person visits, you will meet with study team members including doctors, nurses, and dietitians for an evaluation and physical assessment. The study also involves blood draws, food and exercise diaries review, and diet and physical activity counseling. You will be asked to use the injectable study drug or placebo as directed throughout the study.

Incentives

Information provided upon request, Study oversight by a well qualified medical team including doctors, nurses and dietitians; evaluation of lab work by an expert study team, physical assessments, blood glucose monitor, dietary and physical activity counseling.

In-person visits:
20-24

Phone or online visits:
7

Total length of participation:
2.5 years

Looking for Specific Volunteers

Able to participate:

You have a BMI greater than or equal to 27
You have 2 weight-related complications or risk factors for cardiovascular diseases
You have a history of at least one self-reported unsuccessful dietary effort to lose body weight
You have a BMI of 30 or greater and have established heart disease or chronic kidney disease

Not eligible if:

You have had previous treatment with glucagon-like peptide-1 receptor (GLP-1R) agonists within 3 months.
You have a gastric emptying abnormality
History of either chronic or acute pancreatitis
You have had acute or unstable cardiovascular events within the past month
Personal or family history of medullary thyroid carcinoma

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Eastowne Medical Office Building
100 Eastowne Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Klara Klein
Medicine-Endocrinology

Study Type

Clinical or Medical
Interventional

Study Topics

Heart and Circulation
Kidneys and Liver
Obesity
Wellness and Lifestyle

IRB Number

23-2375

ClinicalTrials.gov

NCT06077864