A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes
Recruiting · NCT07351058 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
EnicepatidePlacebo
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 20 US states.
- Lakeview Clinical Research - Guntersville, Alabama, United States
- Arizona Clinical Trials - Tucson, Arizona, United States
- Orange County Research Center - Lake Forest, California, United States
- Ark Clinical Research - Long Beach, California, United States
- Catalina Research Institute, LLC - Montclair, California, United States
- Infinity Clinical Research - Norco, California, United States
- Prospective Research Innovations Inc. - Rancho Cucamonga, California, United States
- Encompass Clinical Research - Spring Valley, California, United States
- Emerson Clinical Research Institute - Washington D.C., District of Columbia, United States
- Tampa Bay Medical Research, Inc. - Clearwater, Florida, United States
- Center for Diabetes, Obesity and Metabolism Inc - Pembroke Pines, Florida, United States
- Progressive Medical Research - Port Orange, Florida, United States
- Eirvera, LLC - St. Petersburg, Florida, United States
- Centricity Research Columbus Georgia Multispecialty - Columbus, Georgia, United States
- Rophe Adult and Pediatric Medicine/SKYCRNG - Union City, Georgia, United States
- Elite Clinical Trials - Blackfoot, Idaho, United States
- Elevate Clinical Research - Lake Charles, Louisiana, United States
- Nola Care Clinical Research Center - Metairie, Louisiana, United States
- DelRicht Clinical Research, LLC - New Orleans, Louisiana, United States
- Centennial Medical Group - Columbia, Maryland, United States
- Olive Branch Family Medical Center - Olive Branch, Mississippi, United States
- Kansas City VA Medical Center - Kansas City, Missouri, United States
- Centricity Research Morehead City Multispeciality - Morehead City, North Carolina, United States
- Wake Forest University Health Sciences - Winston-Salem, North Carolina, United States
- Remington Davis Inc - Columbus, Ohio, United States
- Lynn Institute of Norman - Norman, Oklahoma, United States
- Lynn Health Science Institute - Oklahoma City, Oklahoma, United States
- Essential Medical Research - Tulsa, Oklahoma, United States
- VA Pittsburgh Healthcare System - Pittsburgh, Pennsylvania, United States
- Coastal Carolina Research Center - North Charleston, South Carolina, United States
- Circle Clinical Research - Sioux Falls, South Dakota, United States
- Headlands Research Brownsville - Brownsville, Texas, United States
- Velocity Clinical Research - Dallas, Texas, United States
- South Texas Research Institute - Edinburg - Edinburg, Texas, United States
- HRI ? Medical Center, LLC - Houston, Texas, United States
- Juno Research, LLC - Houston, Texas, United States
- HRI ? Pasadena, LLC - Pasadena, Texas, United States
- Pinnacle Clinical Research - San Antonio - San Antonio, Texas, United States
- DM Clinical Research - Tomball, Texas, United States
- Manassas Clinical Research Center - Manassas, Virginia, United States
- Centricity Research Suffolk Primary Care - Suffolk, Virginia, United States
- Era Health Research - Redmond, Washington, United States
- Aberdeen Royal Infirmary - Aberdeen, United Kingdom
- Adana Sehir Egitim ve Arastirma Hastanesi - Adana, Turkey (Türkiye)
- Kasugai Municipal Hospital - Aichi, Japan
- Ankara University Medical Faculty - Ankara, Turkey (Türkiye)
- Akdeniz University Medical Faculty - Antalya, Turkey (Türkiye)
- Antrim Area Hospital - Antrim, United Kingdom
- Herz- und Diabeteszentrum NRW Universitätsklinik der Ruhr-Universität Bochum Medizinische Fakultät OWL (Universität Bielefeld);Klinik für Diabetologie und Endokrinologie - Bad Oeynhausen, Germany
- Rajavithi Hospital - Bangkok, Thailand
- Ramathibodi Hospital - Bangkok, Thailand
- Siriraj Hospital - Bangkok, Thailand
- Centro Medico Teknon - Barcelona, Spain
- Hospital Universitari Vall d Hebron - Barcelona, Spain
- Peking University People's Hospital - Beijing, China
- Beijing Pinggu Hospital - Beijing, China
- DIACENTRUM Brandýs nad Labem s.r.o. - Brandýs nad Labem, Czechia
- Southmead General Hospital - Bristol, United Kingdom
- CINME - Buenos Aires, Argentina
- CEDIC Centro de Investigaciones Clinicas - Buenos Aires, Argentina
Showing 60 of 204 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →