DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07271043

RecruitingPhase NA

Nutrition+: Effect of a High-Protein Diabetes Formula on Body Composition in Type 2 Diabetes Patients Treated With Incretin Mimetics

Evaluating the Efficacy of High-Protein Diabetes Specific Formula (HP-DSF) on Body Composition in Overweight/Obese Patients With Type 2 Diabetes Treated With Incretin Mimetic Drugs

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

1

Enrollment

60

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI ≥25

Primary endpoint

•Lean mass

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 IDNCT07271043
Org study IDSTUDY00000322

Timeline

Milestones

Study first posted2025-12-08actual
Study start2026-01-01actual
Last update posted2026-05-29actual
Primary completion2026-11-01estimated
Study completion2026-12-01estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Subject is between 18-75 years of age

2. Subject was diagnosed with type 2 diabetes at least 3 months prior to screening

3. Subject is about to start treatment with an IMD, a GLP-1 receptor agonist (RA) alone or a dual GLP-1/GIP RA. These treatments include either semaglutide (Ozempic®, Wegovy®), tirzepatide (Mounjaro®, Zepbound®), or dulaglutide (Trulicity®)

4. Body mass index (BMI) is ≥ 25 kg/m2

Exclusion criteria

1. Subject has type 1 diabetes mellitus

2. Subject with estimated glomerular filtration rate <60 milliliters/minute/1.73 m²,

3. Urine albumin-to-creatinine ratio (UACR) of 300 mg/g or higher

4. History of acute kidney injury (AKI) during the 6 months prior to screening g.

5. Intolerance or allergy to HP-DSF shake or to any of its ingredients

6. Women who are pregnant or lactating or expect to be pregnant or lactating during the study period.

7. Women of childbearing potential who are not using highly effective contraceptive methods.

Endpoints (1)

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.

Weight & body composition

1 endpoint
Primary/protocol endpoint

Change in lean muscle mass from baseline

Time frame:Endpoints will be analyzed at three months and six months.

Lean mass

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.