GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT06989177

RecruitingPhase NA

Probiotic Intervention on Body Weight

An Interventional Study Investigating the Effects of Probiotics on Body Weight and Metabolic Homeostasis

Lead sponsor

Chinese Academy of Sciences

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

140

estimated

Study population

Healthy volunteers, Obesity / overweight

Key I/E criterion

•BMI ≤24

Primary endpoint

•Body weight, absolute change (kg)

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 IDNCT06989177

Org study IDHIAS-PITBW-202503

Timeline

Milestones

Study first posted2025-05-25actual

Study start2025-06-10actual

Last update posted2026-03-17actual

Primary completion2026-12-30estimated

Study completion2026-12-31estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age20 Years

Maximum age50 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Aged 20 to 50 years.

•Normal-weight participants: 18.5 kg/m² ≤ Body Mass Index (BMI) < 24 kg/m².

•Overweight or obese participants:

BMI ≥ 28 kg/m², or 24 kg/m² ≤ BMI < 28 kg/m² and a clinical diagnosis meeting semaglutide treatment indications (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, cardiovascular disease, etc.).

•Willingness to participate in this study and provide signed informed consent.

Exclusion criteria

•Abnormal metabolic indicators (meeting any one of the following criteria is grounds for exclusion):

1. Normal weight (18.5 kg/m² ≤ BMI < 24 kg/m²):

1. Waist circumference ≥ 90 cm for men or ≥ 85 cm for women.

2. Fasting glucose ≥ 6.1 mmol/L or 2-hour postprandial glucose ≥ 7.8 mmol/L, or a confirmed diagnosis of diabetes.

3. Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, or currently under antihypertensive treatment.

4. Fasting triglycerides (TG) ≥ 1.7 mmol/L; high-density lipoprotein cholesterol (HDL-C) < 0.9 mmol/L in men or < 1.0 mmol/L in women.

2. Overweight or obese (BMI ≥ 24 kg/m²):

1. Fasting plasma glucose > 11.1 mmol/L or HbA1c > 9%, or previously diagnosed diabetes, or currently using insulin or any antidiabetic medication.

2. Blood pressure ≥ 160/100 mmHg, or clinically diagnosed stage 2 or stage 3 (moderate or severe) hypertension, or currently under antihypertensive treatment.

3. Use of lipid-lowering drugs (e.g., fibrates, bile acid sequestrants, statins, PCSK9 inhibitors) within the past 3 months, or TG ≥ 5.7 mmol/L, or LDL ≥ 4.9 mmol/L.

•Pregnancy or lactation.

•Self-reported weight change of more than 5 kg within the 90 days prior to screening.

•Use of antibiotics, antimicrobials, or anti-inflammatory/analgesic salicylates (e.g., aspirin) within the 3 months prior to screening for 3 days or more.

•Use of estrogen therapy or other hormonal medications within the past 6 months.

•Use of GLP-1 receptor agonists or probiotics within the past 3 months.

•Heavy alcohol consumption (females > 40 g/day, approximately 250 mL of huangjiu [yellow rice wine], or 1000 mL of beer, or 100 mL of liquor per day; males > 80 g/day).

•Severe liver or kidney dysfunction (ALT, AST, or serum creatinine exceeding 3 times the upper limit of normal, UACR ≥ 30 mg/g, or eGFR < 60 mL/min).

•Gastrointestinal diseases affecting digestion and absorption (e.g., severe diarrhea, severe constipation, severe inflammatory bowel disease, peptic ulcer, gallstones, cholecystitis).

•Underwent surgery within the past year (excluding appendectomy or hernia repair).

•Severe cardiovascular or cerebrovascular diseases (e.g., heart failure, myocardial infarction, stroke, acute myocarditis, severe arrhythmia, or receiving interventional therapy).

•Presence of metallic implants such as a cardiac stent or pacemaker.

•Cancer or having received radiation or chemotherapy within the past 5 years.

•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, or a personal history of hyperthyroidism or hypothyroidism.

•Chronic or acute pancreatitis.

•Positive hepatitis B surface antigen (HBsAg), active tuberculosis, HIV, or other infectious diseases.

•Currently participating in another clinical study or having done so within the past 3 months.

•Claustrophobia.

•Any psychiatric disorder such as attention-deficit/hyperactivity disorder (ADHD), bipolar disorder, or epilepsy (including current use of antiepileptic medications), or use of antidepressant medications.

•Inability to read, write, operate a smartphone, or perform daily activities independently.

Endpoints (37)

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

Other (unclassified)

Glycemic / diabetes

Weight & body composition

MASH / liver

Weight & body composition

6 endpoints

Primary/protocol endpoint

Change in Body Weight (kg) from Baseline to Week 12

Time frame:Baseline and Week 12

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference (cm) from Baseline to Week 12

Time frame:Baseline and Week 12

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Hip Circumference (cm) from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Fat Mass (kg) from Baseline to Week 12

Time frame:Baseline and Week 12

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change in Fat-free Mass (kg) from Baseline to Week 12

Time frame:Baseline (week 0) and Week 12

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight from Week 12 to 6 months post-intervention

Time frame:Post-intervention 6 months

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

9 endpoints

Secondary/protocol endpoint

Change in Fasting Glucose (mmol/L) from Baseline to Week 12

Time frame:Baseline and Week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Glucose Incremental AUC (mmol·min/L) from Baseline to Week 12

Time frame:Baseline and Week 12

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in HbA1c (%) from Baseline to Week 12

Time frame:Baseline (Week 0) and Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Mean 24-h Glucose (mg/dL) from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Glucose Coefficient of Variation (CV, %) from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Fasting Insulin (µIU/mL) from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Insulin Incremental AUC (µIU·min/mL) from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, descriptive

Secondary/protocol endpoint

Change in Fasting C-peptide (ng/mL) from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in C-peptide Incremental AUC (ng·min/mL) from Baseline to Week 12

Time frame:Baseline and Week 12

C-peptide AUC

change from baseline, improvement

MASH / liver

1 endpoint

Secondary/protocol endpoint

Change in Controlled Attenuation Parameter (CAP, dB/m) from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, improvement

Cardiometabolic biomarkers

11 endpoints

Secondary/protocol endpoint

Change in Systolic Blood Pressure (mmHg) from Baseline to Week 12

Time frame:Baseline and Week 12

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Diastolic Blood Pressure (mmHg) from Baseline to Week 12

Time frame:Baseline and Week 12

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in Heart Rate (beats/min) from Baseline to Week 12

Time frame:Baseline and Week 12

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Fasting Serum Triglycerides (mmol/L) from Baseline to Week 12

Time frame:Baseline and Week 12

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Triglyceride Incremental AUC (mmol·min/L) from Baseline to Week 12

Time frame:Baseline and Week 12

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Serum Fasting Total Cholesterol (mmol/L) from Baseline to Week 12

Time frame:Baseline and Week 12

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Total Cholesterol Incremental AUC (mmol·min/L) from Baseline to Week 12

Time frame:Baseline and Week 12

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C, mmol/L) from Baseline to Week 12

Time frame:Baseline and Week 12

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in HDL-c Incremental AUC (mmol·min/L) from Baseline to Week 12

Time frame:Baseline and Week 12

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C, mmol/L) from Baseline to Week 12

Time frame:Baseline and Week 12

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in LDL-c Incremental AUC (mmol·min/L) from Baseline to Week 12

Time frame:Baseline and Week 12

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Other (unclassified)

10 endpoints

Secondary/protocol endpoint/low confidence

Change in Energy Expenditure Rate (kcal/min) from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Respiratory Quotient from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Fat Oxidation Rate (g/min) from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Carbohydrate Oxidation Rate (g/min) from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in GLP-1 Incremental AUC (pg·min/mL) from Baseline to Week 12

Time frame:Baseline (Week 0) and Week 12

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in GIP Incremental AUC (pg·min/mL) from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Ghrelin Incremental AUC (pg·min/mL) from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Shannon Diversity Index from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Relative Abundance of Akkermansia muciniphila (%) from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Single Nucleotide Polymorphisms (SNPs)

Time frame:Baseline

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.