Obesity, Overweight, Type 2 Diabetes Mellitus (T2DM)
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) 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.
Interventions
COMBINATION_PRODUCTEnicepatide
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
COMBINATION_PRODUCTPlacebo
Participants will receive matching placebo via SC injection as per the schedule in the protocol.
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Body Weight at Week 52 | Baseline through Week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving ≥5% Body Weight Loss at Week 52 | At Week 52 |
| Percentage of Participants Achieving ≥10% Body Weight Loss at Week 52 | At Week 52 |
| Percentage of Participants Achieving ≥15% Body Weight Loss at Week 52 | At Week 52 |
| Percentage of Participants Achieving ≥20% Body Weight Loss, in Participants Receiving Enicepatide Dose 2 and Dose 3 | At Week 52 |
| Change From Baseline in Body Weight at Week 52 | Baseline through Week 52 |
| Change From Baseline in Waist Circumference at Week 52 | Baseline through Week 52 |
| Change From Baseline in Fasting Glucose at Week 52 | Baseline through Week 52 |
| Change From Baseline in Fasting Insulin at Week 52 | Baseline through Week 52 |
| Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 52 | Baseline through Week 52 |
| Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 52 | Baseline through Week 52 |
| Change From Baseline in Triglyceride at Week 52 | Baseline through Week 52 |
| Change From Baseline in Systolic Blood Pressure at Week 52 | 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 | 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 | Baseline through Week 52 |
| Percent Change From Baseline in Body Weight at Week 52 in GLP-1 RA-based Treatment Naive Populations | Baseline through Week 52 |
| Change From Baseline in Waist-to-Hip Ratio at Week 52 | Baseline through Week 52 |
| Change From Baseline in Waist-to-Height Ratio at Week 52 | Baseline through Week 52 |
| Percentage of Participants With Prediabetes at Baseline Achieving Normoglycemia (Hemoglobin A1c [HbA1c] <5.7%) at Week 52 | 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 | 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 | Baseline through Week 52 |
| Change From Baseline in Non-HDL Cholesterol at Week 52 | Baseline through Week 52 |
| Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 52 | Baseline through Week 52 |
| Change From Baseline in Total Cholesterol at Week 52 | Baseline through Week 52 |
| Change From Baseline in Free Fatty Acids at Week 52 | Baseline through Week 52 |
| Change From Baseline in Diastolic Blood Pressure at Week 52 | Baseline through Week 52 |
| Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 52 | Baseline through Week 52 |
| Change From Baseline in Serum Uric Acid at Week 52 | Baseline through Week 52 |
| Percentage of Participants Achieving ≥25% Body Weight Loss at Week 52, in Participants Receiving Enicepatide Dose 2 and Dose 3 | Baseline through Week 52 |
| Change From Baseline in Body Mass Index (BMI) at Week 52 | Baseline through Week 52 |
| Percent Change From Baseline in Body Weight by Obesity Class at Week 52 | Baseline through Week 52 |
| Change From Baseline in HbA1c at Week 52 in Participants With T2DM | Baseline through Week 52 |
| Percentage of Participants With T2DM Achieving HbA1c of <5.7%, ≤6.5% and <7% at Week 52 | At Week 52 |
| Change From Baseline in Total Lean Tissue Volume at Week 52 | Baseline through Week 52 |
| Percent Change From Baseline in Total Lean Tissue Volume at Week 52 | Baseline through Week 52 |
| Change From Baseline in Total Adipose Tissue Volume at Week 52 | Baseline through Week 52 |
| Percent Change From Baseline in Total Adipose Tissue Volume at Week 52 | Baseline through Week 52 |
| Incidence and Severity of Adverse Events, With Severity Determined According to Mild, Moderate, and Severe Criteria | Baseline to Safety Follow-Up (55 Weeks) |
| Change From Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Baseline through Week 52 |
| Change From Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score | Baseline through Week 52 |
Countries
China
Contacts
CONTACTReference Study ID Number: YC46401 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