Clinical trial
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes
Recruiting now · Phase 3 · 5 countries · Registry ID NCT07351058
Recruiting nowPhase 3Interventional
What this study 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).
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity or Overweight, Type 2 Diabetes Mellitus
Full registry 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
Treatments and study arms
Placebo
Combination Product
Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.
Enicepatide
Combination Product
Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.
Primary outcomes
Percent (%) Change from Baseline in Body Weight at Week 72Baseline through Week 72
Study locations
193 locations were listed when this page was built. The first 40 are shown.
CEDIC Centro de Investigaciones Clinicas🇦🇷 Buenos Aires, Argentina
CINME🇦🇷 Buenos Aires, Argentina
Centro Medico Viamonte SRL🇦🇷 Buenos Aires, Argentina
IME - Instituto Médico Especializado🇦🇷 Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada🇦🇷 Ciudad Autonoma Buenos Aires, Argentina
Instituto centenario🇦🇷 Ciudad Autonoma Buenos Aires, Argentina
Centro de Investigaciones Medicas Mar Del Plata🇦🇷 Mar del Plata, Argentina
Paratus Clinical Western Sydney🇦🇺 Blacktown, New South Wales, Australia
Royal Prince Alfred Hospital🇦🇺 Camperdown, New South Wales, Australia
Heidelberg Repatriation Hospital🇦🇺 Heidelberg, Victoria, Australia
Logan Hospital🇦🇺 Meadowbrook, Queensland, Australia
Baker Heart and Diabetes Insitute🇦🇺 Melbourne, Victoria, Australia
Southern Adelaide Diabetes and Endocrine Services (SADES)🇦🇺 Oaklands Park, South Australia, Australia
Clinica do Coracao🇧🇷 Aracaju, Sergipe, Brazil
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás🇧🇷 Goiânia, Goiás, Brazil
Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil
IBPCLIN Instituto Brasil de Pesquisa Clinica🇧🇷 Rio de Janeiro, Brazil
CPQuali Pesquisa Clinica Ltda🇧🇷 São Paulo, São Paulo, Brazil
Centro de Pesquisas Clinicas🇧🇷 São Paulo, São Paulo, Brazil
Centricity Research Brampton Endocrinology🇨🇦 Brampton, Ontario, Canada
Centricity Research Calgary Endocrinology🇨🇦 Calgary, Alberta, Canada
Medicor Research Inc🇨🇦 Greater Sudbury, Ontario, Canada
Applied Medical Informatics Research Inc. (A.M.I.R.)🇨🇦 Montreal, Quebec, Canada
Clinique des maladies lipidiques de Quebec🇨🇦 Québec, Canada
Diex Recherche Sherbrooke🇨🇦 Sherbrooke, Quebec, Canada
LMC Clinical Research Inc🇨🇦 Toronto, Ontario, Canada
TGElliott Inc. dba BC Diabetes🇨🇦 Vancouver, British Columbia, Canada
Beijing Pinggu Hospital🇨🇳 Beijing, China
Peking University People's Hospital🇨🇳 Beijing, China
Cangzhou People's Hospital🇨🇳 Cangzhou, Hebei, China
The First Hospital of Jilin University🇨🇳 Changchun, China
The Second People's Hospital of Hefei🇨🇳 Hefei, China
Huizhou Central People's Hospital🇨🇳 Huizhou, China
Jinan Central Hospital🇨🇳 Jinan, Shandong, China
Huai He Hospital of Henan University🇨🇳 Kaifeng, Henan, China
Hebei Petro China Central Hospital🇨🇳 Langfang, China
The First Affiliated Hospital of Henan University of Science and Technology🇨🇳 Luoyang, China
Affiliated Drum Tower Hospital of Nanjing University Medical School🇨🇳 Nanjing, China
The Second Affiliated Hospital of Nanjing Medical University🇨🇳 Nanjing, China
The First Affiliated Hospital of Ningbo University🇨🇳 Ningbo, Zhejiang, China