GLP-1 Peptide Atlas, by Delfa

RecruitingPhase NA

Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events

Adjuvant Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events During the Up-titration Phase

Lead sponsor

Ariel University

Assets

Semaglutide / Tirzepatide

Listed sites

Recruiting sites

Enrollment

120

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoints

•Gastrointestinal symptoms assessment•Defecation texture•Bowel Movement (BM) frequency

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 IDNCT06431308

Org study IDASMC-0003-24

Timeline

Milestones

Study first posted2024-05-28actual

Study start2025-01-30actual

Last update posted2025-04-24actual

Primary completion2026-02-01estimated

Study completion2026-03-30estimated

Assets

Investigational agents

Semaglutide Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•individuals aged ≥ 18 years

•eligible to receive AOM [i.e., BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with at least one adiposity-related coexisting condition (e.g., diabetes or pre-diabetes, hypertension, dyslipidemia, obstructive sleep apnea, fatty liver, cardiovascular disease)]

•who can read and speak Hebrew.

Exclusion criteria

•Contraindications or precautious for treatment with Wegovy© or Mounjaro© [i.e., personal or family history of medullary thyroid cancer (MTC), personal history of multiple endocrine neoplasia type 2 (MEN2) syndrome, attempting conception, current pregnancy or breastfeeding]

•previous bariatric surgery or endo-bariatric procedure

•presence of chronic pancreatitis

•treatment with AOM within a month before enrollment

•patients with type 1 diabetes mellitus

•patients who underwent other major GI surgery prior to medication treatment

•patient with underlying GI disease [e.g., gastroparesis, celiac, Inflammatory Bowel Disease (IBD)]

•a positive diagnosis of small-intestinal bacterial overgrowth (SIBO)

•patients with active gastritis, gastroenteritis

•chronic usage of promotility drugs or laxatives

•patients with uncontrolled mental illness

•significant cognitive deterioration

•alcohol consumption exceeding 1 drink per day for women and 2 drinks per day for men .

In addition, participants who decide not to initiate or stop Wegovy© or Mounjaro© treatment for more than two consecutive injections for any reason or who undergo bariatric surgery or endoscopic sleeve gastroplasty during the study period will be excluded from the study

Endpoints (32)

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

Other clinical outcomes

Other (unclassified)

Safety / tolerability / PK

Patient-reported / QoL

Weight & body composition

8 endpoints

Secondary/protocol endpoint

Anthropometric measures - weight

Time frame:Change from baseline at the end of the study period (20 weeks)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Anthropometric measures - waist circumference (WC)

Time frame:Change from baseline at the end of the study period (20 weeks)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Body composition - fat mass (kg)

Time frame:Change from baseline at the end of the study period (20 weeks)

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Functional parameters - muscle strength

Time frame:Change from baseline at the end of the study period (20 weeks)

change from baseline, improvement

Secondary/protocol endpoint

Anthropometric measures - height (cm)

Time frame:Change from baseline at the end of the study period (20 weeks)

change from baseline, descriptive

Secondary/protocol endpoint

Body composition- percentage of body fat (BF%)

Time frame:Change from baseline at the end of the study period (20 weeks)

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Body composition - fat-free mass (kg)

Time frame:Change from baseline at the end of the study period (20 weeks)

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Body composition - skeletal muscle mass (kg)

Time frame:Change from baseline at the end of the study period (20 weeks)

Lean mass

change from baseline, improvement

Patient-reported / QoL

4 endpoints

Secondary/protocol endpoint

Eating habits assessment - Control of Eating

Time frame:Change from baseline at the end of the study period (20 weeks)

change from baseline, improvement

Secondary/protocol endpoint

Quality of life assessment

Time frame:Change from baseline at the end of the study period (20 weeks)

EQ-5D VAS

change from baseline, improvement

Secondary/protocol endpoint

Eating habits assessment - Food preferences

Time frame:Change from baseline at the end of the study period (20 weeks)

change from baseline, improvement

Other/protocol endpoint

Lifestyle factors - Sleeping habits

Time frame:Baseline and at the end of the study period (20 weeks)

change from baseline, improvement

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Gastrointestinal symptoms assessment

Time frame:Baseline and at the end of the study period (20 weeks)

change from baseline, event

Primary/protocol endpoint

Defecation texture

Time frame:Baseline and at the end of the study period (20 weeks)

descriptive

Primary/protocol endpoint

Bowel Movement (BM) frequency

Time frame:Baseline and at the end of the study period (20 weeks)

categorical status, descriptive

Primary/protocol endpoint

Participants gastrointestinal symptoms report

Time frame:Baseline, at the end of the study period (20 weeks) and weekly until 20 weeks (for subjective GI symptoms report only)

descriptive

Secondary/protocol endpoint

Incretin-based AOM treatment discontinuation rate

Time frame:At the end of the study period (20 weeks) and weekly until 20 weeks

Discontinuation due to AE

event count, event

Other/protocol endpoint

Number of participants using regular medications and their types

Time frame:Baseline and at the end of the study period (20 weeks)

descriptive

Other clinical outcomes

7 endpoints

Secondary/protocol endpoint/low confidence

Eating habits assessment

Time frame:Change from baseline at the end of the study period (20 weeks)

change from baseline, descriptive

Secondary/protocol endpoint

Functional parameters- leg strength and endurance

Time frame:Change from baseline at the end of the study period (20 weeks)

change from baseline, improvement

Other/protocol endpoint

Health status - Number of participants with coexisting medical conditions and their types

Time frame:Baseline and at the end of the study period (20 weeks)

descriptive

Other/protocol endpoint

Smoking habits

Time frame:Baseline and at the end of the study period (20 weeks)

categorical status, descriptive

Other/protocol endpoint/low confidence

Lifestyle factors - frequency of physical activity

Time frame:Baseline and at the end of the study period (20 weeks)

change from baseline, descriptive

Other/protocol endpoint

Lifestyle factors - duration of physical activity

Time frame:Baseline and at the end of the study period (20 weeks)

change from baseline, descriptive

Other/protocol endpoint

Lifestyle factors - type of physical activity

Time frame:Baseline and at the end of the study period (20 weeks)

categorical status, descriptive

Other (unclassified)

7 endpoints

Secondary/protocol endpoint/low confidence

Dietary intake

Time frame:Change from baseline at the end of the study period (20 weeks)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Biochemical tests

Time frame:At baseline

descriptive

Other/protocol endpoint

Demographics - age

Time frame:At baseline

descriptive

Other/protocol endpoint

Demographics - marital status

Time frame:At baseline

descriptive

Other/protocol endpoint

Demographics - education

Time frame:At baseline

descriptive

Other/protocol endpoint

Demographics - occupation status

Time frame:At baseline

descriptive

Other/protocol endpoint/low confidence

Number of participants using supplementation and their Types

Time frame:Baseline and at the end of the study period (20 weeks)

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.