Obesity or Overweight, Type 2 Diabetes Mellitus
Conditions
Brief summary
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_PRODUCTPlacebo
Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.
COMBINATION_PRODUCTEnicepatide
Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent (%) Change from Baseline in Body Weight at Week 72 | Baseline through Week 72 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving ≥5% Body Weight Loss from Baseline at Week 72 | Baseline and Week 72 |
| Percentage of Participants Achieving ≥10% Body Weight Loss from Baseline at Week 72 | Baseline and Week 72 |
| Percentage of Participants Achieving ≥15% Body Weight Loss from Baseline at Week 72 | Baseline and Week 72 |
| Change from Baseline in Body Weight (kg) at Week 72 | Baseline through Week 72 |
| Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72 | Baseline through Week 72 |
| Percentage of Participants Achieving HbA1c of ≤6.5% at Week 72 | Week 72 |
| Percentage of Participants Achieving HbA1c of <7% at Week 72 | Week 72 |
| Change from Baseline in Waist Circumference (cm) at Week 72 | Baseline through Week 72 |
| Change from Baseline in Fasting Glucose at Week 72 | Baseline through Week 72 |
| Change from Baseline in Fasting Insulin at Week 72 | Baseline through Week 72 |
| Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 72 | Baseline through Week 72 |
| Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 | Baseline through Week 72 |
| Change from Baseline in Triglyceride at Week 72 | Baseline through Week 72 |
| Change from Baseline in Systolic Blood Pressure at Week 72 | 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 | 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 | Baseline through Week 72 |
| Change from Baseline in Waist-to-Hip Ratio at Week 72 | Baseline through Week 72 |
| Change from Baseline in Waist-to-Height Ratio at Week 72 | Baseline through Week 72 |
| Change from Baseline in Subscale Scores of the Control of Eating Questionnaire (CoEQ) at Week 72 | 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 | 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 | 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 | Baseline and Week 72 |
| Percentage of Participants Experiencing No Change, Improvement, or Worsening on the PGI-C Physical Functioning Questionnaire at Week 72 | Baseline and Week 72 |
| Percentage of Participants Experiencing No Change, Improvement, or Worsening on the PGI-S Physical Functioning Questionnaire at Week 72 | 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 | Baseline through Week 72 |
| Change from Baseline in HRQoL as Assessed by the IWQoL-Lite-CT Domain Scores and Total Score at Week 72 | Baseline through Week 72 |
| Change from Baseline in Non-HDL Cholesterol at Week 72 | Baseline through Week 72 |
| Change from Baseline in VLDL Cholesterol at Week 72 | Baseline through Week 72 |
| Change from Baseline in Total Cholesterol at Week 72 | Baseline through Week 72 |
| Change from Baseline in Free Fatty Acids at Week 72 | Baseline through Week 72 |
| Change from Baseline in Diastolic Blood Pressure at Week 72 | Baseline through Week 72 |
| Change from Baseline in High-Sensitivity C-reactive Protein (hsCRP) at Week 72 | Baseline through Week 72 |
| Change from Baseline in Urinary Albumin/Creatinine Ratio at Week 72 | Baseline through Week 72 |
| Change from Baseline in Body Mass Index (BMI) at Week 72 | Baseline through Week 72 |
| Percent (%) Change from Baseline in Body Weight by Obesity Class at Week 72 | Baseline through Week 72 |
| Time to Achieve ≥5%, ≥10%, or ≥15% Body Weight Loss from Baseline Through Week 72 | From Baseline through Week 72 |
| Percentage of Participants Achieving HbA1c of <5.7% at Week 72 | Week 72 |
| Incidence and Severity of Adverse Events, with Severity Determined According to Mild/Moderate/Severe Criteria | Baseline through Week 72 |
| Change from Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score Through Week 72 | Baseline through Week 72 |
| Change from Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score Through Week 72 | Baseline through Week 72 |
Countries
Argentina, Australia, Brazil, Canada, China, Czechia, France, Germany, Italy, Japan, Mexico, Poland, Puerto Rico, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTReference Study ID Number: WC45726 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed