A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes

Phase 3RecruitingNCT07351058

Hoffmann-La Roche1,600 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,600

Conditions

Obesity or Overweight Type 2 Diabetes Mellitus

Interventions

PlaceboCOMBINATION_PRODUCT

Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.

EnicepatideCOMBINATION_PRODUCT

Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (204)

Outcomes

Primary Outcomes

Percent (%) Change from Baseline in Body Weight at Week 72

Time frame: Baseline through Week 72

Secondary Outcomes

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

Central Contacts

Reference Study ID Number: WC45726 https://forpatients.roche.com/ No attachments to email below.

CONTACT

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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...and 194 more locations

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

Change from Baseline in Systolic Blood Pressure at Week 72

Time frame: Baseline through Week 72

Change from Baseline in the Physical Functioning Domain Score of the Short Form (36) Health Survey Version 2 (SF-36v2) Acute Form at Week 72

Time frame: Baseline through Week 72

Change from Baseline in Physical Functioning Composite Score of the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) Questionnaire at Week 72

Time frame: Baseline through Week 72

Change from Baseline in Waist-to-Hip Ratio at Week 72

Time frame: Baseline through Week 72

Change from Baseline in Waist-to-Height Ratio at Week 72

Time frame: Baseline through Week 72

Change from Baseline in Subscale Scores of the Control of Eating Questionnaire (CoEQ) at Week 72

Time frame: Baseline through Week 72

Change from Baseline in Symptoms and Impact of Urinary Incontinence as Assessed by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) at Week 72

Time frame: Baseline through Week 72

Percentage of Participants Experiencing No Change, Improvement, or Worsening on the Patient Global Impression of Change (PGI-C) Urinary Incontinence Questionnaire at Week 72

Time frame: Baseline and Week 72

Percentage of Participants Experiencing No Change, Improvement, or Worsening on the Patient Global Impression of Severity (PGI-S) Urinary Incontinence Questionnaire at Week 72

Time frame: Baseline and Week 72

Percentage of Participants Experiencing No Change, Improvement, or Worsening on the PGI-C Physical Functioning Questionnaire at Week 72

Time frame: Baseline and Week 72

Percentage of Participants Experiencing No Change, Improvement, or Worsening on the PGI-S Physical Functioning Questionnaire at Week 72

Time frame: Baseline and Week 72

Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the SF-36v2 Acute Form Domain Scores and Component Summary Scores at Week 72

Time frame: Baseline through Week 72

Change from Baseline in HRQoL as Assessed by the IWQoL-Lite-CT Domain Scores and Total Score at Week 72

Time frame: Baseline through Week 72

Change from Baseline in Non-HDL Cholesterol at Week 72

Time frame: Baseline through Week 72

Change from Baseline in VLDL Cholesterol at Week 72

Time frame: Baseline through Week 72

Change from Baseline in Total Cholesterol at Week 72

Time frame: Baseline through Week 72

Change from Baseline in Free Fatty Acids at Week 72

Time frame: Baseline through Week 72

Change from Baseline in Diastolic Blood Pressure at Week 72

Time frame: Baseline through Week 72

Change from Baseline in High-Sensitivity C-reactive Protein (hsCRP) at Week 72

Time frame: Baseline through Week 72

Change from Baseline in Urinary Albumin/Creatinine Ratio at Week 72

Time frame: Baseline through Week 72

Change from Baseline in Body Mass Index (BMI) at Week 72

Time frame: Baseline through Week 72

Percent (%) Change from Baseline in Body Weight by Obesity Class at Week 72

Time frame: Baseline through Week 72

Time to Achieve ≥5%, ≥10%, or ≥15% Body Weight Loss from Baseline Through Week 72

Time frame: From Baseline through Week 72

Percentage of Participants Achieving HbA1c of <5.7% at Week 72

Time frame: Week 72

Incidence and Severity of Adverse Events, with Severity Determined According to Mild/Moderate/Severe Criteria

Time frame: Baseline through Week 72

Change from Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score Through Week 72

Time frame: Baseline through Week 72

Change from Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score Through Week 72

Time frame: Baseline through Week 72