Clinical trial

A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes

Recruiting now · Phase 3 · 6 countries · Registry ID NCT07351045

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 without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.

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

Full registry criteria

Inclusion Criteria: * Participants must have at screening: 1. Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or 2. BMI ≥27.0 kg/m\^2 and \<30.0 kg/m\^2 with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease * History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight * Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations) Exclusion Criteria: * History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since. * 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) * History of acute or chronic pancreatitis or clinically significant gallbladder disease. History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening. * Poorly controlled hypertension at screening * 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. * Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder). Participants with MDD or generalized anxiety disorder whose disease state is considered stable within 1 year prior to screening and expected to remain stable throughout the course of the study, in the opinion of the investigator, are allowed provided that they are not receiving prohibited medication. * 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

195 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
Heidelberg Repatriation Hospital🇦🇺 Heidelberg, Victoria, Australia
Baker Heart and Diabetes Insitute🇦🇺 Melbourne, Victoria, Australia
Southern Adelaide Diabetes and Endocrine Services (SADES)🇦🇺 Oaklands Park, South Australia, Australia
Royal North Shore Hospital🇦🇺 St Leonards, New South Wales, Australia
AZORG Campus Aalst-Moorselbaan🇧🇪 Aalst, Belgium
Hospital Erasme🇧🇪 Brussels, Belgium
UZ Leuven Gasthuisberg🇧🇪 Leuven, Belgium
CHU de Liège (Sart Tilman)🇧🇪 Liège, Belgium
AZ Delta (Campus Rumbeke)🇧🇪 Roeselare, Belgium
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás🇧🇷 Goiânia, Goiás, Brazil
Hospital Universitário Onofre Lopes - UFRN🇧🇷 Natal, Rio Grande do Norte, Brazil
Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Base de Sao Jose do Rio Preto🇧🇷 São José do Rio Preto, São Paulo, Brazil
BR Trials - Pesquisa Clínica🇧🇷 São Paulo, São Paulo, Brazil
CPQuali Pesquisa Clinica Ltda🇧🇷 São Paulo, São Paulo, Brazil
Centro de Pesquisas Clinicas🇧🇷 São Paulo, São Paulo, Brazil
Aggarwal and Associates🇨🇦 Brampton, Ontario, Canada
C-health Partners Inc🇨🇦 Calgary, Alberta, Canada
Hamilton Medical Research Group🇨🇦 Hamilton, Ontario, Canada
Wharton Medical Clinic🇨🇦 Hamilton, Ontario, Canada
Alpha Recherche Clinique🇨🇦 Québec, Canada
Bluewater Clinical Research Group🇨🇦 Sarnia, Ontario, Canada
Unity Healthcare Clinic🇨🇦 Surrey, British Columbia, Canada
Diex Recherche Trois-Rivieres🇨🇦 Trois-Rivières, Quebec, Canada
Beijing Pinggu Hospital🇨🇳 Beijing, China
Peking University People's Hospital🇨🇳 Beijing, 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
Hebei Petro China Central Hospital🇨🇳 Langfang, China
The First Affiliated Hospital of Henan University of Science and Technology🇨🇳 Luoyang, China