Not yet recruitingPhase 3

A Research Study to Look at How Well Zenagamtide Works Compared to Placebo in People With Established Atherosclerotic Cardiovascular Disease and Either Overweight or Obesity

Zenagamtide Use for the Reduction of Risk of Major Adverse Cardiovascular Events in People With Established Atherosclerotic Cardiovascular Disease and Either Overweight or Obesity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe zenagamtide is and how well it works in people with artery disease caused by fatty buildup who are overweight or have obesity. Half will get zenagamtide, and half will get a placebo with no active medicine, chosen by chance. Zenagamtide is a study medicine that doctors cannot yet prescribe.

This clinical study is being conducted to evaluate the safety and effectiveness of zenagamtide in people with atherosclerotic cardiovascular disease (ASCVD) and excess body weight compared with placebo. The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have ASCVD and excess body weight. Participants will be randomly assigned by chance to receive either zenagamtide, the investigational treatment being tested, or a placebo, which contains no active medicine. Half of the participants will receive zenagamtide, and treatment assignment will be determined randomly. Zenagamtide is a new investigational medicine that is not yet available for prescription by doctors.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must have had a heart attack, a stroke, or one of the listed forms of artery disease in your legs.
  • Qualifying leg artery disease means pain when walking with an ankle-to-arm blood pressure ratio below 0.85 at rest, or a leg or foot removed at or above the ankle because of fatty buildup in arteries.
  • If you have type 2 diabetes, your treatment must have been stable for at least 90 days before screening, as judged by the study doctor.
  • Diabetes medicines must follow local prescribing rules. GLP-1, GIP, and amylin medicines are not allowed. If you use insulin, only basal (background) insulin is allowed.

Who can't join

  • A heart attack, stroke, unstable chest pain, or worsening heart failure that led to a hospital stay or water-removing medicine given into a vein, from 30 days before screening through assignment to a study group.
  • A procedure to restore blood flow in heart, neck, or limb arteries, or a heart valve repair or replacement through a thin tube, within 30 days before screening or planned during the study.
  • Long-term heart failure identified at screening.
  • Repeated episodes of severely low blood sugar in the past year, or a known history of not noticing low blood sugar.
  • A history of type 1 diabetes.
  • Diabetes-related eye damage treated with laser, surgery, or anti-VEGF medicine within 180 days before screening, or expected to need treatment within 180 days after screening. An eye exam must check for this damage.
  • An HbA1c result above 10% at screening. This blood test measures average blood sugar.
  • Use of any GLP-1, GIP, or amylin medicine for any reason before screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Established ASCVD is defined as at least one of the below conditions (a-c): a. Prior myocardial infarction (MI) b. Symptomatic peripheral artery disease (PAD) defined as at least one of the following: i. Intermittent claudication with an ankle-brachial index (ABI) less than (\<) 0.85 at rest ii. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis) c. Cerebrovascular disease defined as the following: i. Prior stroke * Participants with Type 2 Diabetes (T2D) (at screening) are allowed in the study with the following provisions: 1. Treatment should be stable for greater than or equal to (≥) 90 days before screening as assessed by the investigator. 2. Glucose lowering agents are permitted according to local label except glucagon-like peptide-1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) and amylin analogues; for insulins, only basal insulin is allowed. Exclusion Criteria: * MI, stroke, unstable angina pectoris, or worsening heart failure (HF) leading to either hospitalization or intravenous loop diuretics within 30 days prior to the day of screening and until randomization. * Coronary, carotid, or peripheral artery revascularization or percutaneous valve repair or replacement within 30 days prior to the day of screening or planned during the study period and known at screening. * Chronic heart failure classified at screening. * Glycaemia-related: 1. Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator. 2. Known history of hypoglycaemia unawareness as indicated by the investigator according to Clarke's questionnaire question 8. 3. History of type 1 diabetes (T1D). 4. Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or who, at the time of screening, are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. 5. Glycated haemoglobin (HbA1c) greater than (\>) 10 percentage (%) (86 millimoles per mole \[mmol/mol\]) as measured by central laboratory at screening. * General health and safety: 1. Treatment with any GLP-1 RA, GIP RA or amylin analogue for any indication before screening.

Study sites (155)

AL

AZ

CA

CT

FL

GA

IA

ID

IL

IN

KS

KY

LA

MD

MI

MO

NC

ND

NE

NH

NV

NY

OH

OK

PA

SC

TN

TX

UT

VA

WA

WI