CompletedPhase NA

Effect of a Low-carbohydrate Diet on Weight Loss in People Using the Injectable GLP-1 Agonist Semaglutide for Weight Loss

Effect of a Low-carbohydrate Diet on Weight Loss in People Using the Injectable GLP-1 Agonist Semaglutide for Weight Loss: a Pilot Trial

Lead sponsor

INQUIS Clinical Research

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥26•HbA1c ≤7.5%

Primary endpoint

•Body weight, % change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07280403

Org study IDINQ-2411

Timeline

Milestones

Study start2024-09-12actual

Primary completion2025-10-14actual

Study completion2025-11-30actual

Study first posted2025-12-12actual

Last update posted2026-02-18actual

Assets

Investigational agents

GLP-1 / incretin class catch-all Semaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Aged 18-75 years, inclusive

•Overweight or obese individuals with a BMI ≥26 kg/m²

•Non-pregnant, non-lactating individuals who are not planning on becoming pregnant during the trial and are using an effective method of contraception, as outlined: (a) Complete abstinence from intercourse two weeks prior to administration of the study product, and throughout the clinical trial. Participants utilizing this method must agree to use 2 alternate methods of contraception (see

d)if they should become sexually active and will be queried on whether they have been abstinent at each study visit.

b)Has a male sexual partner who is surgically sterilized prior to the Screening Visit and is the only male sexual partner for that Participant;

c)Sexual partner(s) is/are exclusively female;

d)Use of two acceptable methods of contraception, such as a spermicide, mechanical barrier (e.g. male condom, female diaphragm), tubal ligation, contraceptive pill, intrauterine device (IUD) or contraceptive implant. The Participant must be using these methods for at least 1 week prior to the screening visit and throughout their participation in the trial.

•Started semaglutide injections for weight loss 14 to 35 days prior to screening, inclusive, are tolerating it and are willing to continue taking it

•HbA1c ≤7.5%

•Not taking any hypoglycemic agent, apart from a semaglutide

•Systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg

•Serum creatinine <180 mmol/L (<2.1 mg/dL)

•Serum triglycerides <9 mmol/L (<800 mg/dL)

•ALT or AST <3 times the upper limit of normal

•Untreated LDL-cholesterol <5.00 mmol/l (<193 mg/dL)

•No major illness, trauma or surgery requiring hospitalization within 3mo of the screening visit

•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 are willing to sign the informed consent prior to any procedures conducted

Exclusion criteria

•Failure to meet any one of the inclusion criteria

•High alcohol consumption (>14 standard drinks per week or >4 standard drinks per day for males; and > 7 standard drinks per week or >3 standard drinks per day for females), with 1 standard drink defined as containing approximately 14g of pure alcohol. Examples of 1 standard drink include: 12 oz of regular beer (approx. 5% alcohol), 5 oz of wine (approx. 12% alcohol) or 1.5 oz of distilled spirits (approx. 40% alcohol)

•Individuals with a history of bariatric surgery, gastrointestinal disease, any other medical conditions or use of supplements or medications that increase risk to the subject or others or may affect the results, as judged by the Principal Investigator

•Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines

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

•Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement, or lifestyle modification

Endpoints (8)

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

Weight & body composition

Glycemic / diabetes

Weight & body composition

5 endpoints

Primary/protocol endpoint

Body weight

Time frame:12 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

BMI

Time frame:12 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Fat Mass

Time frame:12 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Fat-free mass

Time frame:12 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Skeletal Muscle Mass

Time frame:12 weeks

Lean mass

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Fasting plasma glucose

Time frame:12 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Fasting serum insulin

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Insulin sensitivity index

Time frame:12 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.