DelfaGLP-1 Atlas

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Active not recruitingPhase 2

A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Daily RO7795081 Administered for 38 Weeks to Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity

Lead sponsor

Hoffmann-La Roche

Asset

CT-996 / RO7795081

Oral · GLP-1 agonist

Listed sites

36

Recruiting sites

—

Enrollment

352

actual

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoint

•Body Weight

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 IDNCT07081958
Org study IDBP45702

Timeline

Milestones

Study first posted2025-07-24actual
Study start2025-07-29actual
Primary completion2026-04-28actual
Last update posted2026-05-07actual
Study completion2026-07-17estimated

Assets

Investigational agents

CT-996 / RO7795081

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Participants must have at screening:

1. Body mass index (BMI) greater than or equal to (≥)30.0 kg/m^2; or

2. BMI ≥27.0 kg/m^2 and <30.0 kg/m^2 with at least one weight-related comorbidity, such as hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, cardiovascular disease

•History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
•A stable body weight for the 3 months prior to screening (maximum 5% body weight gain and/or loss)

Exclusion criteria

•Have a history or diagnosis of any type of diabetes mellitus (Type 1 diabetes [T1D], T2D, or rare forms of diabetes)
•Have 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)
•Participation in unbalanced/extreme diets or in an organized weight reduction program within 3 months of the screening visit or planning to engage in such diets or programs during the study
•Prior or planned surgical treatment for obesity
•Have a known, clinically significant gastric emptying abnormality
•Have poorly controlled hypertension, untreated renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension
•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.
•Have a history of acute or chronic pancreatitis
•Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder), or had a suicide attempt within the last 1 year of screening

Endpoints (12)

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
8
Safety / tolerability / PK
3
Patient-reported / QoL
1

Weight & body composition

8 endpoints
Primary/protocol endpoint

Percent Change in Body Weight From Baseline to Week 30

Time frame:Baseline to Week 30

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute Change in Body Weight (kg) from Baseline to Week 30

Time frame:Baseline to Week 30

change from baseline, improvement

Secondary/protocol endpoint

Absolute Change in Body Weight (kg) from Baseline to Week 38

Time frame:Baseline to Week 38

change from baseline, improvement

Secondary/protocol endpoint

Percent Change in Body Weight From Baseline to Week 38

Time frame:Baseline to Week 38

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 30

Time frame:Baseline and Week 30

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 38

Time frame:Baseline and Week 38

threshold achievement, improvement

Secondary/protocol endpoint

Absolute Change in BMI (kg/m^2) from Baseline to Week 30

Time frame:Baseline to Week 30

change from baseline, improvement

Secondary/protocol endpoint

Absolute Change in BMI (kg/m^2) from Baseline to Week 38

Time frame:Baseline to Week 38

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Change in Patient Health Questionnaire-9 (PHQ-9) Scores from Baseline to Week 42

Time frame:Baseline to Week 42

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Incidence of Adverse Events (AEs), Adverse Events of Special Interest (AESIs), and Serious AEs (SAEs)

Time frame:From first dose until 28 days after the final dose of study treatment (42 weeks)

event count, event

Secondary/protocol endpoint

Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from Baseline to Week 42

Time frame:Baseline to Week 42

change from baseline, event

Secondary/protocol endpoint

Plasma Concentrations of RO7795081 at Prespecified Timepoints

Time frame:Predose on Day 1 and at prespecified timepoints until Week 38

concentration, descriptive

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.