WeDosify Real World Evidence (RWE) Study: Personalized Semaglutide Dosing in U.S. Adults

Closed Loop Medicine

Status: Enrolling

Conditions: Obesity & Overweight

Study type: Observational

Funder types: Industry

Identifiers

NCT07216651

CLM-OB-001

Details and patient eligibility

About

This research study is studying WeDosify, an interactive web-based Clinical Decision Support tool that assists healthcare professionals in managing adults with excess weight or obesity using a Glucagon-like peptide-1 (GLP-1) drug treatment such as semaglutide.

Full description

Researchers at Amarillo Premier Research, working with Closed Loop Medicine Ltd (CLM), want to improve how excess weight and obesity are managed. There is a need for tools that support more consistent, data-informed and personalized treatment decisions in weight management. This research focuses on subjects who have recently been prescribed semaglutide (Wegovy). Semaglutide is a widely used medicine that helps patients to lose excess weight and belongs to a group of medicines called Glucagon-like peptide 1s (GLP-1s).

Only subjects who are receiving semaglutide treatment as part of their routine weight management will be invited by the study doctor to join this research study. Once consented, the study doctor will have access to a product called WeDosify, an interactive web-based Clinical Decision Support tool that assists healthcare professionals in managing adults with excess weight or obesity using GLP-1 treatment.

Participation in this study will last approximately 3 months and will include approximately 4 consultations, either study visits to the research center or remote consultations

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants must be 18 years or older.
2. Participants must have a diagnosis of either obesity or overweight.
3. Participants must have initiated first-time semaglutide treatment within the past 4-12 weeks for the management of overweight or obesity, in line with United States Prescribing Information (USPI) and the clinical judgment of the responsible Healthcare Professional (HCP).
4. Participants must have access to and be able to use suitable weighing scales to record their weight before or during consultations.
5. Participants must provide written informed consent to participate in this study, including agreeing to adhere to the associated procedures.

Exclusion criteria

1. Participants with conditions that the Healthcare Professional (HCP) deems would prevent effective use of weighing scales and accurate self-monitoring or reporting of body weight.
2. Failure to satisfy the responsible Healthcare Professional (HCP) of fitness to participate for any other reason.

Trial design

20 participants in 1 patient group

Observational semaglutide treated cohort

Description:

This research focuses on adult subjects who have recently been prescribed semaglutide (Wegovy) for obesity or overweight.