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.

NOVO-NN9490-8027 AMAZE 7 Obesity

About this Study:

The purpose of this study is to find out if zenagamtide is safe and effective for treating participants who have excess body weight compared to treatment with semaglutide.

Inclusion Criteria:

1. Body mass index (BMI) at screening ≥ 30.0 kg/m2.
2. Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed:
   1. Liposuction and/or abdominoplasty, if performed > 1 year before screening
   2. Adjustable gastric banding, if the band has been removed > 1 year before screening
   3. Intragastric balloon, if the balloon has been removed > 1 year before screening
   4. Duodenal-jejunal bypass liner (e.g. Endobarrier), if the sleeve has been removed > 1 year before screening
   5. Non-pharmaceutical, non-invasive, biodegradable devices, if last used > 1 year before screening

Exclusion Criteria:

• Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening.
• History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.
• Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues within 1 year before screening.

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.