Join a Cardiovascular Health Study for Overweight/Obese Individuals

Qualified participants must/To qualify, you must:

Basic Criteria:

• Be 45 years or older
• Have a BMI of 27 or higher (overweight or obese)
• Have a history of atherosclerotic cardiovascular disease (ASCVD), such as:

• A past heart attack (MI) 
• A past stroke (ischemic or hemorrhagic)
• Peripheral arterial disease (PAD), shown by symptoms like leg pain when walking, poor circulation, past artery procedures, or an amputation due to blocked arteries

If living with type 2 diabetes (T2DM):

• Diagnosed at least 6 months ago
•  Have an HbA1c between 6.5% and 10%
• Be on stable treatment with diet, exercise, or certain diabetes medications for at least 90 days before screening

The purpose of this study is to find out how safe and effective a study treatment is at helping people with overweight or obesity and type 2 diabetes lose weight, compared to a placebo (a treatment with no active medicine).

You may be able to participate if you:

• Have type 2 diabetes
• Have been on the same diabetes treatment for at least 3 months
• Have a BMI of 27 or higher (your provider can help calculate this)
• Have had a stable weight (no more than 5% change) over the past 3 months

You may not be able to participate if any of the following apply to you:

Weight Loss Procedures

• You have had or are planning weight-loss surgery
  (Procedures like liposuction or tummy tuck are okay if done more than 1 year ago)
• You have had or are planning medical weight-loss devices or procedures
  (Allowed if the device was removed more than 6 months ago)

Medical Conditions

• You have type 1 diabetes
• You have severe heart failure (NYHA Class IV)
• In the past 3 months, you’ve had:
  • A heart attack
  • A stroke
  • A heart procedure (such as stent or bypass)
  • Unstable chest pain
  • A hospital stay for heart failure

About this study: 

This study is looking at a treatment to see how well it works and how safe it is for adults who are overweight or have obesity and do not have type 2 diabetes.

The study has two parts:

• Main phase: where participants receive treatment and researchers track things like weight changes and any side effects
• Extension phase: where participants may continue in the study longer so researchers can understand long-term results and safety

You may be able to take part if you:

• Have a BMI of 30 or higher, or27+ with a related health condition (like high blood pressure, high cholesterol, sleep apnea, or heart disease)
• Have had a stable weight (no major changes) over the past 3 months
• Have tried dieting in the past without long-term success

You may not be able to take part if you:

• Have type 1 or type 2 diabetes
• Have had recent serious heart problems (like a heart attack or stroke in the past 3 months)
• Have severe heart failure
• Have had weight-loss procedures or devices recently
• Have used weight-loss medications in the past 3 months

Why participate?

• Help advance research in heart disease prevention
• Compensation may be available (if applicable)

Study Details: 

Location: Jacksonville, FL 

All study- related care is provided at no cost to you or your insurance company.

Are you struggling to manage your weight? Nature Coast Clinical Research – Crystal River is conducting a clinical research study evaluating an investigational once-monthly injection for weight management. The study is enrolling adults who have obesity, or who are overweight with at least one weight-related health condition (such as high blood pressure, high cholesterol, or Type 2 diabetes). Eligible participants will receive study-related care and lifestyle counseling at no cost. Contact us today to learn more and see if you qualify.

Basic Inclusion Criteria

• Must be 18 years of age or older.
• Must have a body mass index (BMI) of 30 or higher (obesity), OR a BMI of 27.0 to less than 30.0 (overweight) with at least one weight-related health condition such as high blood pressure, high cholesterol, sleep apnea, cardiovascular disease, or Type 2 diabetes.
• Must be motivated to lose at least 20% of your body weight.
• Must be willing to self-inject the study medication (or have a trained family member or caregiver inject it).
• Must not have had bariatric or weight loss surgery.
• Must not have had a weight change greater than 5% in the past 3 months.
• Must not be currently taking weight loss medications such as Ozempic, Wegovy, Mounjaro, Zepbound, or Saxenda (must have stopped at least 3 months before screening).
• Must not have had a recent heart attack, stroke, or serious cardiovascular event within the past 3 months.

Contact Nature Coast Clinical Research – Crystal River to learn more about this clinical trial.

The study information below is from Clinicaltrials.gov. https://clinicaltrials.gov/study/NCT07845500?term=vesper-switch&viewType=Card&rank=1#study-overview

Brief Summary

The purpose of this study is to learn about the safety and effectiveness of berobenatide in adults with overweight or obesity who have already lost weight while taking semaglutide or tirzepatide. The study does not include people with diabetes.

Participants will be in the study for about 11 months.

Eligibility Criteria

Inclusion Criteria:

• Aged ≥18 years.
• Currently taking semaglutide or tirzepatide for obesity management.

Exclusion Criteria:

• Diagnosis of any form of diabetes.
• History of acute or chronic pancreatitis.
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).

For more information about this study, please visit: https://www.pfizerclinicaltrials.com/nct07845500-weight-management-trial

Or call our research office.

The study information below is from Clinicaltrials.gov. https://clinicaltrials.gov/study/NCT07845500?term=vesper-switch&viewType=Card&rank=1#study-overview

Brief Summary

The purpose of this study is to learn about the safety and effectiveness of berobenatide in adults with overweight or obesity who have already lost weight while taking semaglutide or tirzepatide. The study does not include people with diabetes.

Participants will be in the study for about 11 months.

Eligibility Criteria

Inclusion Criteria:

• Aged ≥18 years.
• Currently taking semaglutide or tirzepatide for obesity management.

Exclusion Criteria:

• Diagnosis of any form of diabetes.
• History of acute or chronic pancreatitis.
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).

For more information about this study, please visit: https://www.pfizerclinicaltrials.com/nct07845500-weight-management-trial

Or call our research office.