NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07351058

RecruitingPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Obesity or Overweight, Type 2 Diabetes Mellitus

Interventions: Placebo, Enicepatide

Countries: United States, Argentina, Australia, Canada, China, Czechia, France, Germany

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).

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (163)
  • Guntersville, Alabama, United States
  • Tucson, Arizona, United States
  • Lake Forest, California, United States
  • Long Beach, California, United States
  • Montclair, California, United States
  • Norco, California, United States
  • Rancho Cucamonga, California, United States
  • Spring Valley, California, United States
  • Washington D.C., District of Columbia, United States
  • Clearwater, Florida, United States
  • Pembroke Pines, Florida, United States
  • Port Orange, Florida, United States
  • St. Petersburg, Florida, United States
  • Columbus, Georgia, United States
  • Union City, Georgia, United States
  • Lake Charles, Louisiana, United States
  • New Orleans, Louisiana, United States
  • Columbia, Maryland, United States
  • Morehead City, North Carolina, United States
  • Columbus, Ohio, United States
  • Norman, Oklahoma, United States
  • Oklahoma City, Oklahoma, United States
  • Tulsa, Oklahoma, United States
  • Pittsburgh, Pennsylvania, United States
  • North Charleston, South Carolina, United States
  • Sioux Falls, South Dakota, United States
  • Dallas, Texas, United States
  • Edinburg, Texas, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • + 133 more on CT.gov