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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enicepatide Dose 1 | Experimental | Participants will receive enicepatide Dose 1. |
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| Enicepatide Dose 2 | Experimental | Participants will receive enicepatide Dose 2. |
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| Enicepatide Dose 3 | Experimental | Participants will receive enicepatide Dose 3. |
|
| Placebo | Placebo Comparator | Participants will receive matching placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enicepatide | Combination Product | Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Body Weight at Week 52 | Baseline through Week 52 |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Ningbo University(Ningbo First Hospital) | Recruiting | Ningbo | Zhejiang | 315010 | China |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| Placebo | Combination Product | Participants will receive matching placebo via SC injection as per the schedule in the protocol. |
|
| 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 |
| Peking University People's Hospital | Recruiting | Beijing | 100044 | China |
| Shanghai Fifth People's Hospital Affiliated to Fudan University | Recruiting | Shanghai | 201304 | China |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |