Phase
Condition
Diabetes Mellitus, Type 2
Diabetes Prevention
Obesity
Treatment
RO7795068
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ability and willingness to self-administer the study drug (or receive an injectionfrom a trained individual if visually impaired or with physical limitations)
Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification orother locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratorytest at screening, and on stable oral therapy for at least 3 months prior toscreening (if applicable). T2DM may be treated with diet/exercise alone or any oralanti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.
Body mass index (BMI) ≥27.0 kg/m^2
History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
Exclusion
Exclusion Criteria:
History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosisor history of hyperosmolar state/coma within 12 months prior to screening
Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemiaunawareness within the 6 months prior to screening
At least 2 confirmed fasting blood glucose values >270 mg/dL (15.0 mmol/L) (on 2non-consecutive days) during screening
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)
Poorly controlled hypertension at screening
Have any of the following cardiovascular conditions within 3 months prior toscreening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transientischemic attack; Unstable angina; Hospitalization due to congestive heart failure
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
Dr TG Elliott Inc
Vancouver, British Columbia V5Y 3W2
CanadaActive - Recruiting
LMC Clinical Research Inc
Toronto, Ontario M4G 3E8
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
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
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
National Taiwan University Hospital
Taipei, 10048
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei, 112
TaiwanActive - Recruiting
Division of Endocrinology and Metabolism;Internal Medicine
Chiang Mai, 50200
ThailandActive - Recruiting
Lakeview Clinical Research
Guntersville, Alabama 35976
United StatesActive - Recruiting
Arizona Clinical Trials
Tucson, Arizona 85711
United StatesActive - Recruiting
Orange County Research Center
Lake Forest, California 92630
United StatesActive - Recruiting
Ark Clinical Research
Long Beach, California 90815
United StatesActive - Recruiting
Catalina Research Institute, LLC
Montclair, California 91763
United StatesActive - Recruiting
Emerson Clinical Research Institute
Washington D.C., District of Columbia 20009
United StatesActive - Recruiting
Progressive Medical Research
Port Orange, Florida 32127
United StatesActive - Recruiting
Elevate Clinical Research
Lake Charles, Louisiana 70605
United StatesActive - Recruiting
Centennial Medical Group
Columbia, Maryland 21045-5840
United StatesActive - Recruiting
Centricity Research Morehead City Multispeciality
Morehead City, North Carolina 28557
United StatesActive - Recruiting
Remington Davis Inc
Columbus, Ohio 43215
United StatesActive - Recruiting
Essential Medical Research
Tulsa, Oklahoma 74137
United StatesActive - Recruiting
Juno Research, LLC
Houston, Texas 77040
United StatesActive - Recruiting
Era Health Research
Redmond, Washington 98052
United StatesActive - Recruiting

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