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Recruiting NCT07241390

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

Phase III Interventional Atherosclerosis Cardiovascular Disease Chronic Kidney Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Orforglipron, Placebo.
Who it may be relevant to
Registry conditions: Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Argentina, Australia, Austria, Belgium, Brazil +33
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

Overview

The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). Participation in the study will last about 5 years.

Interventions

  • Drug Orforglipron
    Administered orally
  • Drug Placebo
    Administered orally

Primary outcome measures

  • Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events [Time frame: Baseline up to end of study (about 5 years)]
Secondary outcome measures (3)
  • Time to First Occurrence of Composite Endpoint of Major Cardiovascular and Kidney Events [Time frame: Baseline up to end of study (about 5 years)]
  • Change from Baseline in Total eGFR Slope [Time frame: Baseline up to end of study (about 5 years)]
  • Time to Onset of Type 2 Diabetes [Time frame: Baseline up to end of study (about 5 years)]

Eligibility criteria

Inclusion criteria

  • Have established ASCVD and/or CKD

Exclusion criteria

  • Have type 1 diabetes
  • Have had a major heart condition within 60 days prior to screening
  • Have New York Heart Association Functional Classification Class IV heart failure

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Argentina · 59 centers
  • Instituto de Investigaciones Clínicas Bahia Blanca — Bahía Blanca
  • CONEXA Investigacion Clinica S.A. — Buenos Aires
  • Buenos Aires Macula S.A — Buenos Aires
  • CIPREC — Buenos Aires
  • Instituto Médico Especializado (IME) — Buenos Aires
  • Cicemo Srl — Buenos Aires
  • Cardiología Palermo — Buenos Aires
  • Consultorio Medico Investigador Principal Dr Besada — Buenos Aires
  • … and 51 more centers
Mexico · 35 centers

Center list to be confirmed — check the primary protocol.

Brazil · 34 centers

Center list to be confirmed — check the primary protocol.

China · 29 centers

Center list to be confirmed — check the primary protocol.

Netherlands · 23 centers

Center list to be confirmed — check the primary protocol.

India · 20 centers

Center list to be confirmed — check the primary protocol.

Poland · 20 centers

Center list to be confirmed — check the primary protocol.

Romania · 20 centers

Center list to be confirmed — check the primary protocol.

Canada · 19 centers

Center list to be confirmed — check the primary protocol.

Ukraine · 19 centers

Center list to be confirmed — check the primary protocol.

South Korea · 18 centers

Center list to be confirmed — check the primary protocol.

Israel · 17 centers

Center list to be confirmed — check the primary protocol.

Belgium · 16 centers

Center list to be confirmed — check the primary protocol.

Spain · 16 centers

Center list to be confirmed — check the primary protocol.

Australia · 15 centers
  • Nightingale Research — Adelaide
  • Paratus Clinical Research Western Sydney — Blacktown
  • Box Hill Hospital — Box Hill
  • Royal Brisbane and Women's Hospital — Brisbane
  • Paratus Clinical Research Canberra — Bruce
  • Emeritus Research — Camberwell
  • Nightingale Research - Frankston — Frankston
  • Canberra Hospital — Garran
  • … and 7 more centers
Hungary · 15 centers

Center list to be confirmed — check the primary protocol.

Italy · 15 centers

Center list to be confirmed — check the primary protocol.

Taiwan · 15 centers

Center list to be confirmed — check the primary protocol.

Turkey (Türkiye) · 15 centers

Center list to be confirmed — check the primary protocol.

Czechia · 14 centers

Center list to be confirmed — check the primary protocol.

France · 13 centers

Center list to be confirmed — check the primary protocol.

Colombia · 11 centers

Center list to be confirmed — check the primary protocol.

Slovakia · 11 centers

Center list to be confirmed — check the primary protocol.

Bulgaria · 10 centers

Center list to be confirmed — check the primary protocol.

Japan · 10 centers

Center list to be confirmed — check the primary protocol.

Philippines · 10 centers

Center list to be confirmed — check the primary protocol.

Austria · 8 centers
  • VIVIT — Feldkirch
  • Medizinische Universität Graz — Graz
  • Ordensklinikum Linz GmbH Elisabethinen — Linz
  • Cardio Metabolic Centre — Mattersburg
  • Private Practice - Dr. Evelyn Fliesser-Gorzer — Sankt Stefan ob Stainz
  • Klinik Hietzing — Vienna
  • … and 2 more centers
Germany · 8 centers

Center list to be confirmed — check the primary protocol.

Greece · 8 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 8 centers

Center list to be confirmed — check the primary protocol.

Lithuania · 7 centers

Center list to be confirmed — check the primary protocol.

New Zealand · 6 centers

Center list to be confirmed — check the primary protocol.

Serbia · 5 centers

Center list to be confirmed — check the primary protocol.

South Africa · 5 centers

Center list to be confirmed — check the primary protocol.

Estonia · 4 centers

Center list to be confirmed — check the primary protocol.

Malaysia · 4 centers

Center list to be confirmed — check the primary protocol.

Thailand · 3 centers

Center list to be confirmed — check the primary protocol.

Tunisia · 2 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07241390 · 27771 · J2A-MC-GZPW · 2025-523123-22-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗