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CompletedPhase NA

Tolerance of a High Protein Nutrition Shake in Individuals on GLP-1

Tolerance and Acceptance of a High Protein Nutrition Shake in Individuals Treated With the GLP-1 Receptor Agonist Semaglutide: a Single Arm, Open Label Study

Lead sponsor

Kate Farms Inc

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

1

Recruiting sites

Enrollment

20

actual

Study population

Obesity / overweight

Key I/E criteria

BMI ≥27Healthy volunteers

Primary endpoint

Composite GI symptoms score (CSS)

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 IDNCT07096739
Org study IDINQUIS2025

Timeline

Milestones

Study first posted2025-07-31actual
Study start2025-08-01actual
Primary completion2025-09-19actual
Study completion2025-09-19actual
Last update posted2025-12-09actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Generally healthy individuals aged 18-75 years, inclusive
BMI >27.0kg/m²
Taking semaglutide injections (Ozempic or Wegovy) as prescribed (eg. weekly), for at least 4 weeks prior to screening
Ability to understand the study procedures and willing to provide informed consent to participate in the study
Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP
Subjects must have an active e-mail address, daily access to an electronic device (e.g. computer, laptop, tablet, smart phone) and internet, and understand how to complete the daily electronic diary daily

Exclusion criteria

1. Failure to meet any one of the inclusion criteria

2. Use of a compounded GLP-1 agonist

3. Reported history of metabolic (including type 1 and type 2 diabetes mellitus), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, psychiatric disorders, or any other medical conditions that, in the judgment of the Principal Investigator, increase the risk to the subject or others or may affect results

4. Hospital admission for major trauma, or major medical or surgical event, as judged by the Principal Investigator, within 6 months of screening

5. Use of medications such as, but not limited to, hypoglycemic agents, systemic steroids, antipsychotics, or any others that increase the risk to the subject or others or may affect results, as judged by the Principal Investigator

6. Known intolerance, sensitivity, or allergy to any ingredients in the study test products

7. Self-reported pregnancy or breastfeeding or less than 6 weeks postpartum

8. Long term treatment with another investigational drug or other intervention within the last 30 days

9. Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk

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.

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Composite GI symptoms score (CSS)

Time frame:7 days

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.