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

Official title

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight Without Type 2 Diabetes

Overview

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.

Interventions

• Combination product Placebo
  Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.
• Combination product Enicepatide
  Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.

Primary outcome measures

• Percent (%) Change from Baseline in Body Weight at Week 72 [Time frame: Baseline through Week 72]

Secondary outcome measures (12)

• Percentage of Participants Achieving ≥5% Body Weight Loss from Baseline at Week 72 [Time frame: Baseline and Week 72]
• Percentage of Participants Achieving ≥10% Body Weight Loss from Baseline at Week 72 [Time frame: Baseline and Week 72]
• Percentage of Participants Achieving ≥15% Body Weight Loss from Baseline at Week 72 [Time frame: Baseline and Week 72]
• Percentage of Participants Achieving ≥20% Body Weight Loss from Baseline at Week 72 [Time frame: Baseline and Week 72]
• Percentage of Participants Achieving ≥25% Body Weight Loss from Baseline at Week 72 [Time frame: Baseline and Week 72]
• Change from Baseline in Body Weight (kg) at Week 72 [Time frame: Baseline through Week 72]
• Change from Baseline in Waist Circumference (cm) at Week 72 [Time frame: Baseline through Week 72]
• Change from Baseline in Fasting Glucose at Week 72 [Time frame: Baseline through Week 72]
• Change from Baseline in Fasting Insulin at Week 72 [Time frame: Baseline through Week 72]
• Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 72 [Time frame: Baseline through Week 72]
• Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 [Time frame: Baseline through Week 72]
• Change from Baseline in Triglyceride at Week 72 [Time frame: Baseline through Week 72]

Eligibility criteria

Inclusion criteria

• Participants must have at screening:

• Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 36 centers

• Pinnacle Research Group — Anniston
• Alabama Clinical Therapeutics — Birmingham
• University of Alabama at Birmingham — Birmingham
• Arizona Clinical Trials — Tucson
• Artemis Institute for Clinical Research, LLC — San Diego
• Yale University — New Haven
• Rophe Adult and Pediatric Medicine/SKYCRNG — Union City
• East-West Medical Research Institute — Honolulu
• … and 28 more centers

China · 14 centers

• Affiliated Hospital of Jiangsu University — Zhenjiang
• Yan'an University Xianyang Hospital — Xianyang
• Jinan Central Hospital — Jinan
• Peking University People's Hospital — Beijing
• Beijing Pinggu Hospital — Beijing
• The First Hospital of Jilin University — Changchun
• The Second People's Hospital of Hefei — Hefei
• Huizhou Central People's Hospital — Huizhou
• … and 6 more centers

Poland · 10 centers

Center list to be confirmed — check the primary protocol.

France · 9 centers

Center list to be confirmed — check the primary protocol.

Germany · 9 centers

Center list to be confirmed — check the primary protocol.

Spain · 9 centers

Center list to be confirmed — check the primary protocol.

Canada · 8 centers

• C-health Partners Inc — Calgary
• Unity Healthcare Clinic — Surrey
• Aggarwal and Associates — Brampton
• Hamilton Medical Research Group — Hamilton
• Wharton Medical Clinic — Hamilton
• Bluewater Clinical Research Group — Sarnia
• Diex Recherche Trois-Rivieres — Trois-Rivières
• Alpha Recherche Clinique — Québec

Italy · 8 centers

Center list to be confirmed — check the primary protocol.

Taiwan · 8 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 8 centers

Center list to be confirmed — check the primary protocol.

Argentina · 7 centers

• CINME — Buenos Aires
• CEDIC Centro de Investigaciones Clinicas — Buenos Aires
• Centro Medico Viamonte SRL — Buenos Aires
• IME - Instituto Médico Especializado — Buenos Aires
• Instituto centenario — Ciudad Autonoma Buenos Aires
• Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada — Ciudad Autonoma Buenos Aires
• Centro de Investigaciones Medicas Mar Del Plata — Mar del Plata

Hungary · 7 centers

Center list to be confirmed — check the primary protocol.

South Korea · 7 centers

Center list to be confirmed — check the primary protocol.

Czechia · 6 centers

• MUDr. Alena Váchová, Diabetologie — České Budějovice
• Edumed s.r.o.;Diabetologická ambulance — Náchod
• DIALINE s.r.o. — Plze?
• MediSpo Clinic — Prague
• DiaVize — Prague
• … and 1 more center

Japan · 6 centers

Center list to be confirmed — check the primary protocol.

Belgium · 5 centers

• AZORG Campus Aalst-Moorselbaan — Aalst
• Hospital Erasme — Brussels
• UZ Leuven Gasthuisberg — Leuven
• CHU de Liège (Sart Tilman) — Liège
• AZ Delta (Campus Rumbeke) — Roeselare

Australia · 3 centers

• Paratus Clinical Western Sydney — Blacktown
• Southern Adelaide Diabetes and Endocrine Services (SADES) — Oaklands Park
• Baker Heart and Diabetes Insitute — Melbourne

Brazil · 2 centers

• CPQuali Pesquisa Clinica Ltda — São Paulo
• Centro de Pesquisas Clinicas — São Paulo

Netherlands · 2 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07351045 · WC45725 · 2025-523104-71-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗