DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06682351

Not yet recruitingPhase 4

Heterogeneity of Diabetes: Integrated Muli-Omics to Identify Physiologic Subphenotypes and Evaluate Targeted Prevention

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

—

Enrollment

200

estimated

Study population

Obesity / overweight, Prediabetes / glucose intolerance, Type 2 diabetes

Key I/E criteria

•BMI ≥23•HbA1c 5.7-8%

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 IDNCT06682351
Org study ID76481

Timeline

Milestones

Study first posted2024-11-12actual
Last update posted2024-11-12actual
Study start2024-11estimated (month precision)
Primary completion2027-12estimated (month precision)
Study completion2027-12estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Obesity / overweightPrediabetes / glucose intoleranceType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•BMI ≥23 (≥22 in Asians) kg/m2 but < 45 kg/m2
•HbA1c 5.7-8.0% while not on antihyperglycemic medications

Exclusion criteria

•Recent (<6mos) CVD event
•active malignancy, kidney/liver disease pregnancy/lactation, chronic inflammatory disease, eating disorder, bariatric surgery
•history of acute pancreatitis
•family or personal history of medullary thyroid cancer
•current use of antihyperglycemic, diabetogenic, or weight loss medications (washout allowed if approved by primary physician)
•heavy alcohol use
•hct <30, creatinine > 1.4, ALT> 3x ULN
•physical activity >2 hours/day
•inability to come to Stanford CTRU for metabolic testing

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

Cardiometabolic biomarkers
5
Glycemic / diabetes
4
Weight & body composition
2
MASH / liver
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change in body weight

Time frame:At month 0, month 4, month 8, month 11, month 15, month 18

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body fat mass

Time frame:At month 0, month 4, month 8, month 11, month 15, month 18

Total fat mass

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Change in HbA1c

Time frame:At month 0, month 4, month 8, month 11, month 15, month 18

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Time in Range (TIR)

Time frame:At month 0, month 4, month 8, month 11, month 15, month 18

CGM time-in-range

change from baseline, improvement

Secondary/protocol endpoint

HOMA-B

Time frame:At month 0, month 4, month 8, month 11, month 15, month 18

change from baseline, improvement

Secondary/protocol endpoint

HOMA-IR

Time frame:At month 0, month 4, month 8, month 11, month 15, month 18

HOMA-IR (insulin sensitivity)

change from baseline, improvement

MASH / liver

1 endpoint
Secondary/protocol endpoint

Change in alanine transaminase (ALT)

Time frame:At month 0, month 4, month 8, month 11, month 15, month 18

ALT, change

change from baseline, improvement

LOINC 1742-6

Cardiometabolic biomarkers

5 endpoints
Secondary/protocol endpoint

Change in Blood Pressure

Time frame:At month 0, month 4, month 8, month 11, month 15, month 18

change from baseline, improvement

Secondary/protocol endpoint

Change in LDL Cholesterol

Time frame:At month 0, month 4, month 8, month 11, month 15, month 18

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Triglycerides

Time frame:At month 0, month 4, month 8, month 11, month 15, month 18

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in high-sensitivity C-reactive protein (hsCRP)

Time frame:At month 0, month 4, month 8, month 11, month 15, month 18

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in adiponectin

Time frame:At month 0, month 4, month 8, month 11, month 15, month 18

Adiponectin, change

change from baseline, improvement

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.