RecruitingObesity or OverweightType 2 Diabetes Mellitus

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

Eligible age

18+ yrs

Accepts

All genders

Locations

16 states

Healthy volunteers

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About this study

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).

Sponsor: Hoffmann-La Roche

You may qualify if…

✓ 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

You may not qualify if…

✕ 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