A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes

Phase 3RecruitingNCT07670416

Hoffmann-La Roche300 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) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Obesity Overweight Type 2 Diabetes Mellitus (T2DM)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Body mass index (BMI) ≥24.0 kilograms per meter squared (kg/m\^2) for participants with type 2 diabetes mellitus (T2DM) * BMI ≥28.0 kg/m\^2 or BMI ≥24.0 and \<28.0 kg/m\^2 and diagnosed with at least one weight-related comorbidity (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, or weight-related cardiovascular disease) for participants without T2DM * Agreement to adhere to the contraception requirements Exclusion Criteria: * History of Type 1 diabetes mellitus (T1DM) * Obesity induced by other endocrinologic disorders * Any planned major medical procedure or surgery during the study * History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder * Any lifetime history of suicide attempt * History of any hematologic conditions that may interfere with HbA1c measurement * History of acute or chronic pancreatitis or clinically signiﬁcant gallbladder disease * Treatment with any approved or investigational GLP-1-RA-based therapy within 6 months prior to randomization * Treatment with other investigational therapy within 3 months prior to randomization or less than 5 elimination half-lives prior to randomization, whichever is longer * Known allergy to any component of the study drug formulation or any other condition that is a contraindication to GLP-1 RAs or GLP-1/GIP RAs

Locations (21)

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

Yan'an University Xianyang Hospital

Xianyang, Shaanxi, China

RECRUITING

The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)

Ningbo, Zhejiang, China

RECRUITING

Peking University People's Hospital

Beijing, China

RECRUITING

The Second Hospital of Jilin University

Changchun, China

RECRUITING

The Second Affiliated Hospital of Anhui Medical University

Hefei, China

RECRUITING

The Fourth Affiliated Hospital of Harbin Medical University

Herbin, China

RECRUITING

Huai'an First People's Hospital

Huai'an, China

RECRUITING

Huzhou Central Hospital

Huzhou, China

RECRUITING

Jinan Central Hospital

Jinan, China

RECRUITING

...and 11 more locations

Outcomes

Primary Outcomes

Percent Change From Baseline in Body Weight at Week 52

Time frame: Baseline through Week 52

Secondary Outcomes

Percentage of Participants Achieving ≥5% Body Weight Loss at Week 52

Time frame: At Week 52

Percentage of Participants Achieving ≥10% Body Weight Loss at Week 52

Time frame: At Week 52

Percentage of Participants Achieving ≥15% Body Weight Loss at Week 52

Time frame: At Week 52

Percentage of Participants Achieving ≥20% Body Weight Loss, in Participants Receiving Enicepatide Dose 2 and Dose 3

Time frame: At Week 52

Change From Baseline in Body Weight at Week 52

Time frame: Baseline through Week 52

Change From Baseline in Waist Circumference at Week 52

Time frame: Baseline through Week 52

Change From Baseline in Fasting Glucose at Week 52

Time frame: Baseline through Week 52

Change From Baseline in Fasting Insulin at Week 52

Time frame: Baseline through Week 52

Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 52

Time frame: Baseline through Week 52

Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 52

Time frame: Baseline through Week 52

Change From Baseline in Triglyceride at Week 52

Time frame: Baseline through Week 52

Change From Baseline in Systolic Blood Pressure at Week 52

Time frame: Baseline through Week 52

Change From Baseline in the Physical Functioning as Assessed by Short Form 36 Health Survey Acute, Version 2.0 (SF-36 v2 Acute) at Week 52

Time frame: Baseline through Week 52

Change From Baseline in Physical Functioning Composite Score as Assessed by Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) Questionnaire at Week 52

Time frame: Baseline through Week 52

Percent Change From Baseline in Body Weight at Week 52 in GLP-1 RA-based Treatment Naive Populations

Time frame: Baseline through Week 52

Change From Baseline in Waist-to-Hip Ratio at Week 52

Time frame: Baseline through Week 52

Change From Baseline in Waist-to-Height Ratio at Week 52

Time frame: Baseline through Week 52

Percentage of Participants With Prediabetes at Baseline Achieving Normoglycemia (Hemoglobin A1c [HbA1c] <5.7%) at Week 52

Time frame: At Week 52

Change From Baseline in Health Related Quality of Life (HRQoL) as Assessed by the SF-36v2 Acute Domain Scores and Component Summary Scores at Week 52

Time frame: Baseline through Week 52

Change From Baseline in HRQoL as Assessed by the IWQoL-Lite-CT Questionnaire Domain Scores and Total Score at Week 52

Time frame: Baseline through Week 52

Change From Baseline in Non-HDL Cholesterol at Week 52

Time frame: Baseline through Week 52

Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 52

Time frame: Baseline through Week 52

Change From Baseline in Total Cholesterol at Week 52

Time frame: Baseline through Week 52

Change From Baseline in Free Fatty Acids at Week 52

Time frame: Baseline through Week 52

Change From Baseline in Diastolic Blood Pressure at Week 52

Time frame: Baseline through Week 52

Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 52

Time frame: Baseline through Week 52

Change From Baseline in Serum Uric Acid at Week 52

Time frame: Baseline through Week 52

Percentage of Participants Achieving ≥25% Body Weight Loss at Week 52, in Participants Receiving Enicepatide Dose 2 and Dose 3

Time frame: Baseline through Week 52

Change From Baseline in Body Mass Index (BMI) at Week 52

Time frame: Baseline through Week 52

Percent Change From Baseline in Body Weight by Obesity Class at Week 52

Time frame: Baseline through Week 52

Change From Baseline in HbA1c at Week 52 in Participants With T2DM

Time frame: Baseline through Week 52

Percentage of Participants With T2DM Achieving HbA1c of <5.7%, ≤6.5% and <7% at Week 52

Time frame: At Week 52

Change From Baseline in Total Lean Tissue Volume at Week 52

Time frame: Baseline through Week 52

Percent Change From Baseline in Total Lean Tissue Volume at Week 52

Time frame: Baseline through Week 52

Change From Baseline in Total Adipose Tissue Volume at Week 52

Time frame: Baseline through Week 52

Percent Change From Baseline in Total Adipose Tissue Volume at Week 52

Time frame: Baseline through Week 52

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

Time frame: Baseline to Safety Follow-Up (55 Weeks)

Change From Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score

Time frame: Baseline through Week 52

Change From Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score

Time frame: Baseline through Week 52

Central Contacts

Reference Study ID Number: YC46401 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