DelfaGLP-1 Atlas

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UnknownPhase 4

Effect of Liraglutide on Microbiome in Obesity

Could Gut Microbiome Contribute to the Therapeutic Effect of Liraglutide 3.0 mg? A Randomized Double Blind Placebo Controlled Trial

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

70

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Gut microbiome composition

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 IDNCT04046822
Org study IDMicrobiome 1

Timeline

Milestones

Study start2019-01-09actual
Study first posted2019-08-06actual
Last update posted2019-08-20actual
Primary completion2020-01-09estimated
Study completion2020-04-30estimated

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial;

2. Age ≥ 18 years and < 65 years at the time of signing informed consent;

3. Body mass index (BMI) ≥ 30 kg/m2

4. Stable body weight during the previous 3 months (< 5 kg self-reported weight change).

Exclusion criteria

General Safety

1. Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial;

2. Current use or use within three months before this trial of GLP-1 receptor agonist, pramlintide, sibutramine, orlistat, zonisamide, topiramate or phentermine;

3. Type 1 diabetes;

4. Type 2 diabetes;

5. Obesity related to endocrine diseases;

6. Hepatic Failure (AST and/or ALT >3 times upper limit of normal and/or Total Bilirubin >1.7 upper limit of normal)

7. End stage renal disease (eGFR < 30 ml/min/1.73 m2 ) or chronic or intermittent haemodialysis or peritoneal dialysis

8. History or presence of chronic pancreatitis

9. Presence of acute pancreatitis within the past 180 days prior to the day of screening

10. Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma

11. Presence or history of malignant neoplasms within the past 5 years prior to the day of screening

12. Severe psychiatric disorder which in the investigator's opinion could compromise compliance with the protocol

13. Known or suspected hypersensitivity to trial product(s) or related products

14. Previous participation in this trial. Participation is defined as randomisation

15. Receipt of any investigational medicinal product within 30 days before screening

16. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method i.e.:

–patients who use combined hormonal contraceptives (containing estreogen and progesterone) associated with inhibition of ovulation or oral, intravaginal that transdermal;
–patients who use hormonal contraceptives based only progesterone that inhibit ovulation, whether oral, injectable or implantable
–patients with placement of IUD (intrauterine device)
–patients with positioning of hormone releasing intrauterine systems
–patients with bilateral tubal occlusion
–patients with vasectomized partner
–patients who practice sexual abstinence

17. Any disorder, unwillingness or inability, which in the investigator's opinion, might jeopardise the subject's safety or compliance with the protocol

18. Previous surgical treatment for obesity (excluding liposuction >1 year before trial entry); 19 ) Inflammatory bowel diseases; 20 ) recent antibiotic therapy ( within 30 days before screening)

Cardiovascular- related

•Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
•Planned coronary, carotid or peripheral artery revascularisation known on the day of screening;
•Presently classified as being in New York Heart Association (NYHA) Class IV heart failure

Endpoints (21)

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
10
Other (unclassified)
6
Weight & body composition
3
Glycemic / diabetes
2

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Change in body weight (kg) assessed by scale

Time frame:Change from baseline in body weight at weeks 5 (visit 7)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight (kg) that will be combined with height (m) to report BMI (kg/m^2) where kg is a person's weight in kilograms and m2 is a person's height in metres squared

Time frame:Change from baseline in body mass index at weeks 5 (visit 7)

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in body composition assessed by Bioelectrical impedance analysis (BIA)

Time frame:Change from baseline in body composition at weeks 5 (visit 7)

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change in insulin resistance assessed by Matsuda Index

Time frame:Change from baseline in insulin resistance assessed by Matsuda Index at weeks 5 (visit 7)

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change in insulin resistance assessed by homeostasis model assessment - insulin resistance (HOMA-IR) Index

Time frame:Change from baseline in insulin resistance assessed by HOMA-IR Index at weeks 5 (visit 7)

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

10 endpoints
Secondary/protocol endpoint

Change in hormonal regulation of weight assessed by leptin levels

Time frame:Change from baseline in leptin levels at weeks 5 (visit 7)

Leptin, change

change from baseline, improvement

Secondary/protocol endpoint

Change in low grade inflammation assessed by C-reactive protein levels

Time frame:Change from baseline in C-reactive protein levels at weeks 5 (visit 7)

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in low grade inflammation assessed by erythrocyte sedimentation rate (ESR) levels

Time frame:Change from baseline in ESR levels at weeks 5 (visit 7)

change from baseline, improvement

Secondary/protocol endpoint

Change in low grade inflammation assessed by interleukin- 1 (IL- 1) levels

Time frame:Change from baseline in IL- 1 levels at weeks 5 (visit 7)

change from baseline, improvement

Secondary/protocol endpoint

Change in low grade inflammation assessed by interleukin- 6 (IL- 6) levels

Time frame:Change from baseline in IL- 6 levels at weeks 5 (visit 7)

change from baseline, improvement

Secondary/protocol endpoint

Change in low grade inflammation assessed by interleukin- 10 (IL- 10) levels

Time frame:Change from baseline in IL- 10 levels at weeks 5 (visit 7)

change from baseline, improvement

Secondary/protocol endpoint

Change in lipid profile assessed by total cholesterol levels

Time frame:Change from baseline in total cholesterol levels at weeks 5 (visit 7)

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in lipid profile assessed by LDL cholesterol levels

Time frame:Change from baseline in LDL cholesterol levels at weeks 5 (visit 7)

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in lipid profile assessed by HDL cholesterol levels

Time frame:Change from baseline in HDL cholesterol levels at weeks 5 (visit 7)

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in lipid profile assessed by triglycerides levels

Time frame:Change from baseline in triglycerides levels at weeks 5 (visit 7)

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Other (unclassified)

6 endpoints
Primary/protocol endpoint/low confidence

Change in gut microbiome composition assessed by Firmicutes-to-Bacteroidetes ratio using Quantitative polymerase chain reaction (PCR)

Time frame:Change from baseline in gut microbiome composition at weeks 5 (visit 7)

ratio, descriptive

Secondary/protocol endpoint/low confidence

Change in hormonal regulation of appetite assessed by ghrelin levels

Time frame:Change from baseline in ghrelin levels at weeks 5 (visit 7)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in hormonal regulation of hunger suppression assessed by cholecystokinin levels

Time frame:Change from baseline in cholecystokinin levels at weeks 5 (visit 7)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in hormonal regulation of appetite assessed by polipeptide YY levels

Time frame:Change from baseline in polipeptide YY levels at weeks 5 (visit 7)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in low grade inflammation assessed by Tumor Necrosis Factor -α (TNF-α) levels

Time frame:Change from baseline in TNF-α levels at weeks 5 (visit 7)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in low grade inflammation assessed by monocyte chemotactic protein - 1 (MCP-1) levels

Time frame:Change from baseline in MCP-1 levels at weeks 5 (visit 7)

change from baseline, improvement

Publications (5)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.