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A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes

1600 patients around the world

Available in Argentina, United States

Hoffmann-La Roche

1Research sites

1600Patients around the world

This study is for people with

Obesity

Diabetes

Diabetes mellitus type 2

From 18 Years

All Gender

: 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.

: 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.

Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires

Recruiting

Viamonte 2213, C1056ABI Cdad. Autónoma de Buenos Aires, Argentina

StudyEnith2

SponsorHoffmann-La Roche

Study typeInterventional

Conditions

ObesityDiabetes mellitus type 2

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07351058