A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and 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 and 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 with obesity or overweight and Type 2 diabetes mellitus (T2DM).

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]
• Change from Baseline in Body Weight (kg) at Week 72 [Time frame: Baseline through Week 72]
• Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72 [Time frame: Baseline through Week 72]
• Percentage of Participants Achieving HbA1c of ≤6.5% at Week 72 [Time frame: Week 72]
• Percentage of Participants Achieving HbA1c of <7% at Week 72 [Time frame: 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]

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

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 · 35 centers

• Lakeview Clinical Research — Guntersville
• Arizona Clinical Trials — Tucson
• Orange County Research Center — Lake Forest
• Ark Clinical Research — Long Beach
• Catalina Research Institute, LLC — Montclair
• Infinity Clinical Research — Norco
• Prospective Research Innovations Inc. — Rancho Cucamonga
• Encompass Clinical Research — Spring Valley
• … and 27 more centers

China · 20 centers

• Huai He Hospital of Henan University — Kaifeng
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou
• Affiliated Hospital of Jiangsu University — Zhenjiang
• Yan'an University Xianyang Hospital — Xianyang
• Jinan Central Hospital — Jinan
• The First Affiliated Hospital of Ningbo University — Ningbo
• Peking University People's Hospital — Beijing
• Beijing Pinggu Hospital — Beijing
• … and 12 more centers

Germany · 10 centers

Center list to be confirmed — check the primary protocol.

Poland · 10 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 10 centers

Center list to be confirmed — check the primary protocol.

Spain · 9 centers

Center list to be confirmed — check the primary protocol.

Taiwan · 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

Canada · 7 centers

• Centricity Research Calgary Endocrinology — Calgary
• TGElliott Inc. dba BC Diabetes — Vancouver
• Centricity Research Brampton Endocrinology — Brampton
• Medicor Research Inc — Greater Sudbury
• LMC Clinical Research Inc — Toronto
• Diex Recherche Sherbrooke — Sherbrooke
• Clinique des maladies lipidiques de Quebec — Québec

Italy · 7 centers

Center list to be confirmed — check the primary protocol.

Japan · 6 centers

Center list to be confirmed — check the primary protocol.

South Korea · 6 centers

Center list to be confirmed — check the primary protocol.

Thailand · 6 centers

Center list to be confirmed — check the primary protocol.

Australia · 5 centers

• Paratus Clinical Western Sydney — Blacktown
• Royal Prince Alfred Hospital — Camperdown
• Logan Hospital — Meadowbrook
• Southern Adelaide Diabetes and Endocrine Services (SADES) — Oaklands Park
• Baker Heart and Diabetes Insitute — Melbourne

France · 5 centers

• Hopital Saint Joseph Saint Luc — Lyon
• Hopital de la Conception — Marseille
• … and 3 more centers

Czechia · 4 centers

• DIACENTRUM Brandýs nad Labem s.r.o. — Brandýs nad Labem
• Diavital Jesenice s.r.o. — Jesenice
• FLEDIP s.r.o. — Prague
• TreDia s.r.o.;Diabetologická ambulance Praha 9 — Praha 9 - Klánovice

Turkey (Türkiye) · 4 centers

Center list to be confirmed — check the primary protocol.

Mexico · 3 centers

Center list to be confirmed — check the primary protocol.

Puerto Rico · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07351058 · WC45726 · 2025-523106-32-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗