Phase
Condition
Obesity
Diabetes Prevention
Hypertriglyceridemia
Treatment
RO7795068
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants must have at screening:
Body mass index (BMI) greater than or equal to (≥)30.0 kg/m^2; or
BMI ≥27.0 kg/m^2 and <30.0 kg/m^2 with at least one weight-related comorbidity,such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleepapnea, or weight-related cardiovascular disease
History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
Ability and willingness to self-administer the study drug (or receive an injectionfrom a trained individual if visually impaired or with physical limitations)
Exclusion
Exclusion Criteria:
History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis orhyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetesis allowed if no history of diabetes is recorded since.
Self-reported change in body weight >5 kg within 3 months prior to screening
Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) ordiagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptordeficiency or Prader-Willi syndrome)
Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty ifperformed more than 1 year prior to screening is allowed.
Known clinically significant gastric emptying abnormality (e.g., severegastroparesis or gastric outlet obstruction)
History of acute or chronic pancreatitis or clinically significant gallbladderdisease. History of acute pancreatitis caused by gallstones or clinicallysignificant gallbladder disease is allowed if the participant had a cholecystectomyto resolve the problem at least 3 months prior to screening.
Poorly controlled hypertension at screening
Any of the following cardiovascular conditions within 3 months prior to screening:Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemicattack; Unstable angina; Hospitalization due to congestive heart failure.
Have a history of significant active or unstable major depressive disorder (MDD) orother severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or otherserious mood or anxiety disorder). Participants with MDD or generalized anxietydisorder whose disease state is considered stable within 1 year prior to screeningand expected to remain stable throughout the course of the study, in the opinion ofthe investigator, are allowed provided that they are not receiving prohibitedmedication.
Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptortriple agonist) within 6 months prior to randomization
Study Design
Connect with a study center
Paratus Clinical Western Sydney
Blacktown, New South Wales 2148
AustraliaActive - Recruiting
Wharton Medical Clinic
Hamilton, Ontario L8L 5G8
CanadaActive - Recruiting
Hasegawa Medicine Clinic
Hokkaido, 066-0032
JapanActive - Recruiting
Higashijujo Sakai Diabetes Internal Medicine Clinic
Tokyo, 114-0001
JapanActive - Recruiting
Changhua Christian Hospital
Changhua, 50006
TaiwanActive - Recruiting
Chia-Yi Christian Hospital
Chiayi City, 600
TaiwanActive - Recruiting
China Medical University Hospital
Taichung, 40447
TaiwanActive - Recruiting
Chung Shan Medical University Hospital
Taichung, 40201
TaiwanActive - Recruiting
National Cheng Kung University Hospital
Tainan, 70403
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei, 112
TaiwanActive - Recruiting
Pinnacle Research Group
Anniston, Alabama 36207
United StatesActive - Recruiting
Arizona Clinical Trials
Tucson, Arizona 85711
United StatesActive - Recruiting
Artemis Institute for Clinical Research, LLC
San Diego, California 92123
United StatesActive - Recruiting
Elevate Clinical Research
Gurnee, Illinois 60031
United StatesActive - Recruiting
Monroe Biomedical Research
Louisville, Kentucky 40213
United StatesActive - Recruiting
International Diabetes Center At Park Nicollet
Minneapolis, Minnesota 55416
United StatesActive - Recruiting
Clinvest Research LLC
Springfield, Missouri 65807
United StatesActive - Recruiting
Headlands Reseach- Summit
Portland, Oregon 97210
United StatesActive - Recruiting
Trial Management Associates
Myrtle Beach, South Carolina 29572
United StatesActive - Recruiting
Clinical Research Associates
Nashville, Tennessee 37203
United StatesActive - Recruiting
Elevate Clinical
Houston, Texas 77058
United StatesActive - Recruiting
Elevate Clinical
McAllen, Texas 78504
United StatesActive - Recruiting

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