DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07112872

Active not recruitingPhase 2

A Study to Compare Different Doses of RO7795081 With a Placebo or Semaglutide in People With Type 2 Diabetes

A Randomized, Double-Blind, Placebo- and Open-Label Active Comparator- Controlled, Parallel-Group, Multi-Center Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Daily RO7795081 Administered for 30 Weeks to Participants With Type 2 Diabetes Mellitus

Lead sponsor

Hoffmann-La Roche

Assets

CT-996 / RO7795081 / Semaglutide

Listed sites

50

Recruiting sites

—

Enrollment

240

estimated

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥23•HbA1c 7-10.5%

Primary endpoint

•HbA1c, 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 IDNCT07112872
Org study IDBP45703
Secondary ID2024-520322-11-00

Timeline

Milestones

Study first posted2025-08-08actual
Study start2025-08-19actual
Last update posted2026-04-08actual
Primary completion2026-11-27estimated
Study completion2026-11-27estimated

Assets

Investigational agents

CT-996 / RO7795081Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Have a diagnosis of Type 2 diabetes mellitus (T2D) for at least 6 months before screening
•Have an HbA1c ≥7% and ≤10.5% at screening
•Management of T2D with diet and exercise alone or with either a stable dose of metformin or/and sodium-glucose cotransporter-2 (SGLT-2) inhibitors
•Body mass index (BMI) ≥23.0 kg/m^2 at screening
•A stable body weight within 3 months prior to screening (maximum 5% self-reported body weight gain and/or loss)

Exclusion criteria

•Have Type 1 diabetes (T1D), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2D
•Have had 1 or more episodes of Level 3 hypoglycemia or has hypoglycemia unawareness within the 6 months prior to screening
•History or presence of proliferative diabetic retinopathy, diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment
•Evidence of clinically significant/active nephropathy or neuropathy (including resting tachycardia, orthostatic hypotension, and diabetic diarrhea)
•Current treatment or treatment within 3 months of screening with any other anti-hyperglycemic medication except metformin or SGLT-2 inhibitors
•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)
•Have a known, clinically significant gastric emptying abnormality
•Have poorly controlled hypertension at screening, 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

Endpoints (10)

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

Glycemic / diabetes
4
Weight & body composition
3
Safety / tolerability / PK
3

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Percent Change in Body Weight from Baseline at Week 30

Time frame:Baseline to Week 30

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline to Week 30

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and Week 30

≥15% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

RO7795081 vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30

Time frame:Baseline to Week 30

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

RO7795081 vs. Semaglutide: Change in HbA1c from Baseline at Week 30

Time frame:Baseline to Week 30

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants with HbA1c <5.7%, ≤6.5%, and <7.0% at Week 30

Time frame:Week 30

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose from Baseline at Week 30

Time frame:Baseline to Week 30

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

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

Time frame:From first dose until 28 days after the final dose of study treatment (34 weeks)

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

Number of Participants with Documented Hypoglycemia (Level 1, 2, or 3 per American Diabetes Association 2025)

Time frame:From first dose until 28 days after the final dose of study treatment (34 weeks)

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Plasma Concentrations of RO7795081 at Prespecified Timepoints

Time frame:Predose on Day 1 and at prespecified timepoints until Week 30

Plasma concentration (steady state)

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.