A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Obesity or Overweight
Type 2 Diabetes Mellitus
Спонсор: Hoffmann-La Roche
Налично на:
БГ
Обобщение
The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).
Кой може да участва
Inclusion Criteria:
* Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
* Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-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 Criteria:
* History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
* Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
* At least 2 confirmed fasting blood glucose values \>270 mg/dL (15.0 mmol/L) (on 2 non-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) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
* Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
* Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
* Poorly controlled hypertension at screening
* Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure
* Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization
Интервенции
Placebo
COMBINATION_PRODUCT
Enicepatide
COMBINATION_PRODUCT
Места на провеждане
36
Argentina (1)
CINME
Buenos Aires
Австралия (1)
Paratus Clinical Western Sydney
Blacktown , New South Wales
Канада (3)
Centricity Research Brampton Endocrinology
Brampton , Ontario
LMC Clinical Research Inc
Toronto , Ontario
TGElliott Inc. dba BC Diabetes
Vancouver , British Columbia
Япония (3)
Kasugai Municipal Hospital
Aichi
Hasegawa Medicine Clinic
Hokkaido
Higashijujo Sakai Diabetes Internal Medicine Clinic
Tokyo
Taiwan (8)
Changhua Christian Hospital
Changhua
Chia-Yi Christian Hospital
Chiayi City
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Chung Shan Medical University Hospital
Taichung
China Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Тайланд (1)
Division of Endocrinology and Metabolism;Internal Medicine