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

Phase
Recruitment status
Not yet recruiting
Participants
Lead sponsor
Novo Nordisk A/S
Start date
Number of sites

Summary
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.
Acronym
Short title
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
Official title
Zenagamtide Use for the Reduction of Risk of Major Adverse Cardiovascular Events in People With Established Atherosclerotic Cardiovascular Disease and Either Overweight or Obesity

Control arm
Registry reports results
Listing at source
Recruitment status
Not yet recruiting
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Novo Nordisk A/S
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design

  1. Time from randomization to first occurrence of a 4-point (P) composite major adverse cardiovascular events (MACE) endpoint consisting of: Cardiovascular (CV) death, Non-fatal MI, Non-fatal stroke, HF hospitalization or urgent HF visit

    Timeframe: From baseline (week 0) to up to 203 weeks or longer

    Measured in days.

  1. Time from randomization to first occurrence of an expanded 5-P composite MACE endpoint consisting of: All-cause death, Non-fatal MI, Non-fatal stroke, HF hospitalization or urgent HF visit, Coronary revascularization

    Timeframe: From baseline (week 0) to up to 203 weeks or longer

    Measured in days.

  2. Time from randomization to first occurrence of a 3-P composite MACE endpoint consisting of: CV death, Non-fatal MI, Non-fatal stroke

    Timeframe: From baseline (week 0) to up to 203 weeks or longer

    Measured in days.

  3. Change in Estimated Glomerular Filtration Rate (eGFR) (creatinine and cystatin C-based Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021) for participants with baseline eGFR< 60 millilitre per minute per 1.73 square metre (mL/min/1.73 m^2)

    Timeframe: From baseline (week 0) to week 104

    Measured as mL/min/1.73 m\^2.

  4. Time from randomization to all-cause death

    Timeframe: From baseline (week 0) to up to 203 weeks or longer

    Measured in days.

  5. Time from randomization to CV death

    Timeframe: From baseline (week 0) to up to 203 weeks or longer

    Measured in days.

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
45 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility

  • Uni of Alabama at BirminghamBirmingham, United States
  • Eastern Shore Rsrch Inst, LLCFairhope, United States
  • Mobile Heart SpecialistsMobile, United States
  • Chambliss Clinical Trials LLCMontgomery, United States
  • Mercy Gilbert Medical CenterGilbert, United States
  • Sun City Clinical ResearchGlendale, United States
  • Honor HealthScottsdale, United States
  • Clinical Research Institute of ArizonaSurprise, United States
  • National Heart Institute CalBeverly Hills, United States
  • California Inst Of Renal ResChula Vista, United States
  • Valley Clinical TrialsCovina, United States
  • First Valley Medical GroupLancaster, United States
  • Torrance Clin Res Inst, Inc.Lomita, United States
  • Pacific Clinical StudiesLos Alamitos, United States
  • Academic Medical Research InstituteLos Angeles, United States
  • Valley Clinical Trials, Inc.Northridge, United States
  • Desert Oasis Hlthcr Med GroupPalm Springs, United States
  • Clinical Trials Research_SacramentoSacramento, United States
  • Paradigm Clinical ResearchSan Diego, United States
  • N America Res Inst - San DimasSan Dimas, United States
  • Fomat Medical ResearchSanta Maria, United States
  • Bridgeport HospitalBridgeport, United States
  • Innovative Research of W FLClearwater, United States
  • Nature Coast Clin Rsrch_Crystal RiverCrystal River, United States
  • Florida Premier CardiologyDelray Beach, United States

And 744 more, listed on the interactive page.

Sources for sites

  • 2026-525182-53
  • U1111-1335-0048
Sources for references

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)