Recruiting

GLP-1 Receptor Agonist

Sponsor:

Brigham and Women's Hospital

Code:

NCT06069622

Conditions

Overweight and Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

24-hour ambulatory blood pressure

Liberal salt diet

Study Details

Brief summary:

Obesity has become an important public health issue that leads to insulin resistance, diabetes, hypertension, dyslipidemia, and cardiovascular diseases. Although weight loss with calorie restriction and increased physical activity improve these complications, many people fail these lifestyle interventions. Therefore, pharmacologic agents have been used for weight management in addition to lifestyle interventions. In the past few years, one of the widely used pharmacologic agents for weight management is Glucagon-like peptide 1 receptor agonists (GLP1 RAs). Overall, this class of medications improves both metabolic and cardiovascular profiles while causing weight loss, but their effects can vary between individuals. Therefore, it is essential to understand who will respond best to this therapy. Based on previous research on the interaction between a cell membrane molecule, caveolin-1, and glucagon-like peptide 1 receptor, we hypothesize that genetic variations in the caveolin-1 gene explain the variable cardiometabolic responses.

Conditions

Overweight and Obesity

Study ID

NCT06069622

Start date

Nov 1, 2023

Status verified date

Dec, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 years, body mass index (BMI) ≥30.0 kg/m2 or ≥27.0 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, prediabetes, dyslipidemia, obstructive sleep apnea,
  • Normal screening laboratory values,
  • Systolic BP < 160 mmHg and diastolic BP < 95 mmHg as determined from measurement during screening, using a random-zero device in the clinic and normal electrocardiogram, use of anti-hypertensive medications will be allowed except for mineralocorticoid receptor antagonists.

Exclusion Criteria:

  • Diabetes mellitus,
  • Treatment with a glucose-lowering agent(s) or anti-obesity medication within 90 days of screening,
  • Treatment with a GLP-1 receptor agonist within 180 days,
  • Current treatment with beta-blocker, or steroids,
  • Pregnancy,
  • Personal history of pancreatitis,
  • Personal history of cholelithiasis,
  • Previous surgical obesity treatment,
  • Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma,
  • Medical illness other than hypertension, prediabetes, obstructive sleep apnea, or dyslipidemia,
  • Alcohol intake >12 oz. per week,
  • Tobacco, or recreational drug use

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Overweight and Obese individuals

A group of overweight and obese men and women whose body mass index (BMI) is ≥30.0 kg/m2 or ≥27.0 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, prediabetes, dyslipidemia, obstructive sleep apnea whose treating clinicians have elected to start on semaglutide.

Interventions

24-hour ambulatory blood pressure

24-hour ambulatory blood pressure, blood, and urine will be obtained prior to semaglutide therapy and after 20 weeks of semaglutide therapy.

Liberal salt diet

Participants will be on a liberal salt (about 200 mEq sodium/day) diet for 7 days.

Primary outcome measure

  • Blood pressure response to GLP-1 RA treatment [ Time Frame: 20 weeks ]
  • Weight loss response to GLP-1 RA treatment [ Time Frame: 20 weeks ]

Central Contacts and Locations

Central contacts

Ezgi Caliskan Guzelce, M.D.

857-544-4290ecaliskanguzelce@bwh.harvard.edu

Gail K.Adler, M.D.,PhD.

617-732-5666gadler@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Dec 10, 2025

Last verified

Dec, 2025

Keywords

  • GLP-1 receptor agonist
  • Weight loss
  • CAV-1
  • Blood pressure
  • ALDO

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-12-10.