Phase
Condition
Diabetes Prevention
Hypertriglyceridemia
Obesity
Treatment
Tirzepatide
RO7204239
RO7204239 Matching Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
BMI ≥ 30.0 kilograms per square meter (kg/m²) (additional weight-relatedcomorbidities are not required for inclusion)
BMI ≥ 27.0 kg/m² and < 30.0 kg/m² with at least one weight-related comorbidity suchas: hypertension, dyslipidemia, obstructive sleep apnea and any cardiovasculardisease
History of at least one self-reported unsuccessful dietary or exercise effort tolose body weight
Weight stability: self-reported change in body weight less than 5 kilograms (kg) (11pounds [lbs]) within 3 months prior to screening
Exclusion
Exclusion Criteria:
Prior history or diagnosis of DM
Presence of non-proliferative diabetic retinopathy requiring acute therapy,proliferative diabetic retinopathy or diabetic macular edema
Have obesity induced by other endocrinologic disorders
Participation in unbalanced/extreme diets
Prior or planned surgical treatment for obesity
Endoscopic and/or device-based therapy for obesity or device removal within 6 monthsprior to screening
Have a known clinically significant gastric emptying abnormality
Have any of the following cardiovascular conditions within 6 months prior toscreening: acute myocardial infarction, cerebrovascular accident (stroke), unstableangina, or hospitalization due to congestive heart failure (CHF)
Have evidence of significant active, uncontrolled cardiovascular, autoimmune,endocrine, renal, hepatic, dermatological, chronic respiratory or gastrointestinaldisease, a neurological or psychiatric condition, or a history of any neuromusculardisorder or autoimmune/inflammatory disorders that may cause muscle wasting ormedical condition capable of constituting a risk when taking the study medication orinterfering with the interpretation of data, as judged by the investigator atscreening
Have evidence of a significant, uncontrolled endocrine abnormality
Have a history of an active or untreated malignancy or are in remission from aclinically significant malignancy
Have evidence of a significant, active autoimmune abnormality
Have anemia
Have signs and symptoms of any other liver disease other than nonalcoholic fattyliver disease
Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14units per week (females)
Study Design
Connect with a study center
ETG Warszawa
Warszawa, 02-677
PolandActive - Recruiting
Universidad de Sevilla - Hospital Universitario Virgen Macarena
Sevilla, Barcelona 41009
SpainActive - Recruiting
Hospital Vithas Nisa Sevilla
Castilleja de la Cuesta, Granada 41950
SpainActive - Recruiting
Accellacare Yorkshire
Shipley, Yorkshire BD18 3SA
United KingdomActive - Recruiting
Pinnacle Research Group
Anniston, Alabama 36207
United StatesActive - Recruiting
Encompass Clinical Research
Spring Valley, California 91978
United StatesActive - Recruiting
K2 Medical Research South Orlando, LLC
Orlando, Florida 32806
United StatesActive - Recruiting
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia 30291
United StatesActive - Recruiting
Accellacare of Duly Health and Care
Oak Lawn, Illinois 60453
United StatesActive - Recruiting
Rochester Clinical Research
Rochester, New York 14609
United StatesActive - Recruiting
Accellacare of Salisbury
Salisbury, North Carolina 28144
United StatesActive - Recruiting
Rowan Diagnostic Clinic
Salisbury, North Carolina 28144
United StatesActive - Recruiting
Accellacare of Piedmont Healthcare
Statesville, North Carolina 28625
United StatesActive - Recruiting
Accellacare of Wilmington, LLC
Wilmington, North Carolina 28401
United StatesActive - Recruiting
Accellacare Research of Winston Salem
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
NexGen Research
Lima, Ohio 45801
United StatesActive - Recruiting
Accellacare of Bristol/ Internal Medicine & Pediatrics
Bristol, Tennessee 37620
United StatesActive - Recruiting
Accellacare of Knoxville
Knoxville, Tennessee 37912
United StatesActive - Recruiting
Clinical Research Associates
Nashville, Tennessee 37203
United StatesActive - Recruiting
Texas Diabetes & Endocrinology, P.A.
Austin, Texas 78731
United StatesActive - Recruiting
Juno Research, LLC
Houston, Texas 77040
United StatesActive - Recruiting
Consano Clinical Research
Shavano Park, Texas 78231
United StatesActive - Recruiting
Velocity Clinical Research (Impact Research Institute)
Waco, Texas 76710
United StatesActive - Recruiting
Manassas Clinical Research Center
Manassas, Virginia 20110
United StatesActive - Recruiting
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