Enith2

RecruitingPhase 3

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

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight and Type 2 Diabetes

Lead sponsor

Hoffmann-La Roche

Asset

CT-388

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Enrollment

1,600

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27•HbA1c 6.5-10%

Primary endpoint

•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07351058

Org study IDWC45726

Secondary ID2025-523106-32-00

Timeline

Milestones

Study first posted2026-01-20actual

Study start2026-03-23actual

Last update posted2026-05-26actual

Primary completion2028-08-07estimated

Study completion2028-08-07estimated

Assets

Investigational agents

CT-388

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (41)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Patient-reported / QoL

Cardiometabolic biomarkers

Glycemic / diabetes

Safety / tolerability / PK

Renal / kidney

Weight & body composition

11 endpoints

Primary/protocol endpoint

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

Time frame:Baseline through Week 72

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥5% Body Weight Loss from Baseline at Week 72

Time frame:Baseline and Week 72

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥10% Body Weight Loss from Baseline at Week 72

Time frame:Baseline and Week 72

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥15% Body Weight Loss from Baseline at Week 72

Time frame:Baseline and Week 72

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Body Weight (kg) at Week 72

Time frame:Baseline through Week 72

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference (cm) at Week 72

Time frame:Baseline through Week 72

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline through Week 72

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline through Week 72

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline through Week 72

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline through Week 72

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:From Baseline through Week 72

time to event, improvement

Glycemic / diabetes

6 endpoints

Secondary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72

Time frame:Baseline through Week 72

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c of ≤6.5% at Week 72

Time frame:Week 72

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c of <7% at Week 72

Time frame:Week 72

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in Fasting Glucose at Week 72

Time frame:Baseline through Week 72

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change from Baseline in Fasting Insulin at Week 72

Time frame:Baseline through Week 72

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Week 72

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Renal / kidney

1 endpoint

Secondary/protocol endpoint

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

Time frame:Baseline through Week 72

uACR, change

change from baseline, improvement

LOINC 9318-7

Cardiometabolic biomarkers

10 endpoints

Secondary/protocol endpoint

Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 72

Time frame:Baseline through Week 72

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72

Time frame:Baseline through Week 72

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change from Baseline in Triglyceride at Week 72

Time frame:Baseline through Week 72

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure at Week 72

Time frame:Baseline through Week 72

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change from Baseline in Non-HDL Cholesterol at Week 72

Time frame:Baseline through Week 72

Non-HDL cholesterol, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in VLDL Cholesterol at Week 72

Time frame:Baseline through Week 72

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Total Cholesterol at Week 72

Time frame:Baseline through Week 72

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change from Baseline in Free Fatty Acids at Week 72

Time frame:Baseline through Week 72

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Diastolic Blood Pressure at Week 72

Time frame:Baseline through Week 72

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

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

Time frame:Baseline through Week 72

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Patient-reported / QoL

11 endpoints

Secondary/protocol endpoint

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

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

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

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

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, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

PGI, change

categorical status, improvement

Secondary/protocol endpoint

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

PGI, change

categorical status, improvement

Secondary/protocol endpoint

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

PGI, change

categorical status, improvement

Secondary/protocol endpoint

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

PGI, change

categorical status, improvement

Secondary/protocol endpoint

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

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

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

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline through Week 72

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline through Week 72

Treatment-emergent AEs (any)

descriptive

Secondary/protocol endpoint

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, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.