Study Details

Open

Weight Loss Study

The purpose of this study is to determine the efficacy and safety of an investigational oral medication compared with placebo in people with obesity or overweight with and without type 2 diabetes

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 each visit, you will meet with a member of the study team and answer questions about your health. You will be asked to complete diaries, answer questionnaires, measure your blood sugar as instructed by the study team, receive diet and exercise counseling, and follow the instructions of the study doctor. The study also involves fasting blood draws, and EKGs. There is an optional sub-study that involves DXA scans. If you have type 2 diabetes, you will also receive eye exams and diabetes education.

Incentives

Information provided upon request, Blood glucose meter and supplies, study results

In-person visits:
21

Phone or online visits:
2

Total length of participation:
About a year and a half

Looking for Specific Volunteers

Able to participate:

you have a BMI of at least 30, or BMI of at least 25 with type 2 diabetes or a weight-related comorbidity
you have had at least 1 unsuccessful attempt to lose weight by changing your diet
you are willing to self-monitor your blood sugar
your treatment for type 2 diabetes has been stable for the past 3 months (if appliable)
you are willing to take an oral study medication (or placebo) daily

Not eligible if:

you are able to get pregnant and are not willing to use one of the highly effective contraception options outlined by the study
you have type 2 diabetes with an HbA1c of less than 7% OR greater than 10%
you have had a surgical treatment or procedure for weight loss such as gastric band, gastric bypass, sleeve gastrectomy, duodenal switch, or endoscopic sleeve gastroplasty
your body weight has changed by more than 11 lbs in the last 3 months
you are currently using or have used any medications for weight loss, including GLP-1 medications, in the last 3 months

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

Diabetes
Obesity

IRB Number

25-0794

ClinicalTrials.gov

NCT06993792