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Zenagamtide Compared With Placebo in People With Heart Disease and Excess Weight

Tests zenagamtide against placebo in people with atherosclerotic heart disease and excess weight.

Key facts

Who runs it
Novo Nordisk A/S
Where
Buenos Aires, CABA, Capital Federal, City of Buenos Aires, Ciudad Autónoma de Buenos Aires, Córdoba, Corrientes, Formosa, Godoy Cruz, Godoy Cruz, Mendoza, La Plata, Mar del Plata, Río Cuarto, Rosario, Salta, San Martin, San Miguel de Tucumán, San Nicolás, Santa Fe, and Zárate, ArgentinaSee the 29 sitesAlso in 25 other countries, 732 sites
Trial code
Registry 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
Status
Not yet recruiting
Phase
Phase 3
People taking part
8,500 people, planned
Started
26 Oct 2026
Expected to end
16 Sept 2030
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Zenagamtide
  • Placebo
Record updated
6 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 45 to 64 who have established atherosclerotic cardiovascular disease and are overweight or obese. They will get zenagamtide or a placebo.

Age
45 Years to 64 Years
Sex
All sexes can join.
Disease stage
Established atherosclerotic cardiovascular disease: a prior heart attack, symptomatic peripheral artery disease, or a prior stroke. Type 2 diabetes is allowed if treatment has been stable for at least 90 days.
Earlier treatment
People who ever took a GLP-1 RA, GIP RA or amylin analogue cannot join. Type 2 diabetes treatment must be stable for at least 90 days before screening, with only basal insulin allowed.
Biomarker or test result
HbA1c must not be above 10 % (86 mmol/mol) at screening.

Main reasons for not taking part

  • Heart attack, stroke, unstable angina or worsening heart failure needing hospital or IV diuretics within 30 days before screening
  • Artery revascularization or valve repair or replacement within 30 days before screening or planned during the study
  • Chronic heart failure at screening
  • History of type 1 diabetes
  • Recurrent severe low blood sugar episodes in the last year, or hypoglycaemia unawareness

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Established ASCVD is defined as at least one of the below conditions (a-c):; 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:; Treatment should be stable for greater than or equal to (≥) 90 days before screening as assessed by the investigator; 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

Who cannot take part

  • 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
  • General health and safety:; Treatment with any GLP-1 RA, GIP RA or amylin analogue for any indication before screening
  • Chronic heart failure classified at screening
  • Glycaemia-related:; Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator; Known history of hypoglycaemia unawareness as indicated by the investigator according to Clarke's questionnaire question 8; History of type 1 diabetes (T1D); 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; Glycated haemoglobin (HbA1c) greater than (>) 10 percentage (%) (86 millimoles per mole [mmol/mol]) as measured by central laboratory at screening

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 45 and 64 years old?

Where in Argentina

Also in 25 other countries, 732 sites

  • CardiaMetBuenos Aires, ArgentinaContact: Novo NordiskNo longer taking part
  • Kynet RecoletaBuenos Aires, ArgentinaContact: Novo NordiskNo longer taking part
  • Glenny Corp. S.ACABA, ArgentinaContact: Novo NordiskNo longer taking part
  • Centro de Investigaciones MetabólicasCapital Federal, ArgentinaContact: Novo NordiskNo longer taking part
  • IMOBACity of Buenos Aires, ArgentinaContact: Novo NordiskNo longer taking part
  • Centro Médico ArsemaCiudad Autónoma de Buenos Aires, ArgentinaContact: Novo NordiskNo longer taking part
  • CICEMO- Consultorio (Av Directorio)Ciudad Autónoma de Buenos Aires, ArgentinaContact: Novo NordiskNo longer taking part
  • Centro Medico Privado San Vicente DiabetesCórdoba, ArgentinaContact: Novo NordiskNo longer taking part
  • Clinica Privada Velez SarsfieldCórdoba, ArgentinaContact: Novo NordiskNo longer taking part
  • Instituto de Investigaciones Clínicas CórdobaCórdoba, ArgentinaContact: Novo NordiskNo longer taking part
  • Instituto Médico DAMICCórdoba, ArgentinaContact: Novo NordiskNo longer taking part
  • Sanatorio Duarte QuirosCórdoba, ArgentinaContact: Novo NordiskNo longer taking part
  • Instituto de Cardiologia de CorrientesCorrientes, ArgentinaContact: Novo NordiskNo longer taking part
  • Hospital Interdistrital EvitaFormosa, ArgentinaContact: Novo NordiskNo longer taking part
  • CIPADIGodoy Cruz, ArgentinaContact: Novo NordiskNo longer taking part
  • Hospital Español de MendozaGodoy Cruz, Mendoza, ArgentinaContact: Novo NordiskNo longer taking part
  • Instituto Médico PlatenseLa Plata, ArgentinaContact: Novo NordiskNo longer taking part
  • Instituto de Investigaciones Clinicas Mar del PlataMar del Plata, ArgentinaContact: Novo NordiskNo longer taking part
  • Centro de Investigacion de Instituto Medico - CIIMRío Cuarto, ArgentinaContact: Novo NordiskNo longer taking part
  • Fundacion Estudios ClinicosRosario, ArgentinaContact: Novo NordiskNo longer taking part
  • Instituto de Investigaciones Clinicas RosarioRosario, ArgentinaContact: Novo NordiskNo longer taking part
  • Instituto Especialidades de la Salud RosarioRosario, ArgentinaContact: Novo NordiskNo longer taking part
  • Instituto Medico CatamarcaRosario, ArgentinaContact: Novo NordiskNo longer taking part
  • Investigaciones Clinicas Salta (ICSAL)Salta, ArgentinaContact: Novo NordiskNo longer taking part
  • Corporación Médica San MartínSan Martin, ArgentinaContact: Novo NordiskNo longer taking part
  • Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de JulioSan Miguel de Tucumán, ArgentinaContact: Novo NordiskNo longer taking part
  • Instituto de Investigaciones Clinicas San NicolásSan Nicolás, ArgentinaContact: Novo NordiskNo longer taking part
  • Centro de Investigaciones Clinicas del LitoralSanta Fe, ArgentinaContact: Novo NordiskNo longer taking part
  • Instituto de Investigaciones Clinicas ZarateZárate, ArgentinaContact: Novo NordiskNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • ZenagamtideTreatment being tested

    Participants will receive zenagamtide subcutaneously (s.c.) in a dose escalating manner once weekly.

  • PlaceboPlacebo, for comparison

    Participants will receive placebo matched to zenagamtide s.c. once weekly.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Zenagamtide Compared With Placebo in People With Heart Disease and Excess WeightGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07861100, who can take part
Record updated
6 October 2026