DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07392151

Not yet recruitingPhase 3

Reversal to Normoglycemia by Treating Prediabetes

REVERsal to Normoglycemia by Treating PREDIABETES: The REVERT-PREDIABETES Trial

Lead sponsor

Michael Mæng

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

158

estimated

Study population

Cardiovascular disease, Prediabetes / glucose intolerance

Key I/E criterion

—

Primary endpoints

•Presence of a composite of retinopathy, nephropathy, neuropathy, and MASLD (retinopathy, nephropathy, neuropathy, masld)•HbA1c <5.7% achievement

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 IDNCT07392151
Org study ID2025-522970-35-00

Timeline

Milestones

Study first posted2026-02-06actual
Last update posted2026-02-06actual
Study start2026-02estimated (month precision)
Primary completion2029-10estimated (month precision)
Study completion2029-10estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Cardiovascular diseasePrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Chronic coronary syndrome with documented coronary artery disease. In the case of previous myocardial infarction, at least 30 days between the event and randomization is required.
•Prediabetes defined as HbA1c 42-47 mmol/mol (IEC criteria) OR normoglycemia defined as HbA1c <39 mmol/mol
•Age 18 to 80 years

Exclusion criteria

•eGFR <30 mL/min/1.73 m2
•Previous diabetes diagnosis, previous HbA1c >47 mmol/mol, or current/previous usage of diabetes medication
•Anemia, recent bleeding or blood transfusion (<3 months)
•Previous pancreatitis
•Pregnancy, breastfeeding, or fertile women who do not use highly effective contraception
•Strongly reduced liver function
•Chronic alcohol abuse
•Known hemoglobinopathy and other conditions with effect on erythrocyte lifespan
•Intake of medications with known effect on HbA1c validity such as: antiretroviral medications, trimethoprim, sulfamethoxazole, sulfasalazine hydroxyurea, dapsone, acetylsalicylic acid (>3 g/daily), high dose vitamin C and E.
•Heart failure with NYHA class III or IV Trial subjects must be capable of giving informed consent as assessed by the investigator.

Patients with BMI<25 kg/m2 will be assessed individually by an investigator for eligibility (e.g., whether initiation of a GLP-1 RA with potential weight loss is clinically justifiable).

Endpoints (35)

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
12
Cardiometabolic biomarkers
6
Renal / kidney
5
Weight & body composition
4
MASH / liver
3
Other clinical outcomes
3
Other (unclassified)
2

Weight & body composition

4 endpoints
Secondary/protocol endpoint

Change in weight

Time frame:1-year follow-up

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:1-year follow-up

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in weight

Time frame:2-year follow-up

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:2-year follow-up

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

12 endpoints
Primary/protocol endpoint

Incidence of normoglycemia defined as HbA1c <39 mmol/mol

Time frame:1-year follow-up

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Incidence of normoglycemia defined as HbA1c <42 mmol/mol

Time frame:1-year follow-up

HbA1c <6.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c

Time frame:1-year follow-up

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in c-peptide

Time frame:1-year follow-up

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

Change in HOMA-IR

Time frame:1-year follow-up

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Prevalence of HbA1c ≥42 mmol/mol

Time frame:2-year follow-up

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Incidence of type 2 diabetes

Time frame:2-year follow-up

Time to T2DM onset

time to event, event

Secondary/protocol endpoint

Prevalence of prediabetes defined as HbA1c 42-47 mmol/mol

Time frame:2-year follow-up

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Prevalence of prediabetes defined as HbA1c 39-47 mmol/mol

Time frame:2-year follow-up

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c

Time frame:2-year follow-up

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in c-peptide

Time frame:2-year follow-up

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

Change in HOMA-IR

Time frame:2-year follow-up

HOMA-IR (insulin sensitivity)

change from baseline, improvement

MASH / liver

3 endpoints
Secondary/protocol endpoint

Change in Fib-4

Time frame:1-year follow-up

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in MASLD severity

Time frame:1-year follow-up

change from baseline, improvement

Secondary/protocol endpoint

Change in Fib-4

Time frame:2-year follow-up

change from baseline, improvement

Renal / kidney

5 endpoints
Secondary/protocol endpoint

Change in eGFR

Time frame:1-year follow-up

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change in cystatin-C

Time frame:1-year follow-up

change from baseline, improvement

Secondary/protocol endpoint

Change in urine albumin-creatinine ratio

Time frame:1-year follow-up

uACR, change

ratio, improvement

LOINC 9318-7

Secondary/protocol endpoint

Change in eGFR

Time frame:2-year follow-up

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change in cystatin-C

Time frame:2-year follow-up

change from baseline, improvement

Cardiometabolic biomarkers

6 endpoints
Secondary/protocol endpoint

Change in hs-CRP

Time frame:1-year follow-up

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in lipid parameters

Time frame:1-year follow-up

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in CD163

Time frame:1-year follow-up

change from baseline, improvement

Secondary/protocol endpoint

Change in hs-CRP

Time frame:2-year follow-up

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint/low confidence

Change in lipid parameters

Time frame:2-year follow-up

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in CD163

Time frame:2-year follow-up

change from baseline, improvement

Other clinical outcomes

3 endpoints
Primary/protocol endpoint/low confidence

Presence of a composite of retinopathy, nephropathy, neuropathy, and MASLD

Time frame:Baseline

categorical status, descriptive

componentsretinopathy, nephropathy, neuropathy, masld

Secondary/protocol endpoint

Presence of: Retinopathy, Nephropathy, Neuropathy, or MASLD

Time frame:Baseline

categorical status, descriptive

componentsretinopathy, nephropathy, neuropathy, masld

Secondary/protocol endpoint/low confidence

Presence of a composite of retinopathy, nephropathy, and neuropathy.

Time frame:Baseline

categorical status, event

componentsretinopathy, nephropathy, neuropathy

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Change in PRO-C3

Time frame:1-year follow-up

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in PRO-C3

Time frame:2-year follow-up

change from baseline, 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.