DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT05751720

UnknownPhase 1, PHASE2

Effect on Non-Alcoholic Fatty Liver Disease in Patients With Type 2 Diabetes Mellitus With Gastric Inhibitory Polypeptide/Glucagon Like Peptide-1 Analogue

Effect on Non-Alcoholic Fatty Liver Disease With Advanced Fibrosis in Patients With Type 2 Diabetes Mellitus on Treatment With Gastric Inhibitory Polypeptide / Glucagon Like Peptide-1 Analogue (Tirzpatide)

Lead sponsor

Dr Adnan Agha

Assets

Semaglutide / Tirzepatide

Listed sites

1

Recruiting sites

1

Enrollment

30

estimated

Study population

MASH / NAFLD / liver fibrosis, Type 2 diabetes

Key I/E criterion

•BMI ≥19

Primary endpoints

•Liver stiffness (VCTE), change•MRI-PDFF, % change

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 IDNCT05751720
Org study IDUAEU_CMHS_IM_startup_AA01

Timeline

Milestones

Study first posted2023-03-02actual
Study start2023-10-01actual
Last update posted2024-01-12actual
Primary completion2024-10estimated (month precision)
Study completion2025-02estimated (month precision)

Assets

Investigational agents

SemaglutideTirzepatide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age99 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Age > 18; either male or female
•Diagnosed to have Type 2 Diabetes Mellitus for > 1 year.
•Presence of NAFLD advanced fibrosis (F3 and F4; defined by NFS of > 0.676)
•Able to consent independently
•Not already on GLP-1 analogues or SGLT2 inhibitors or pioglitazone
•Good general health
•BMI> 19 but less than 40

Exclusion criteria

•Known history of alcohol excess or current alcohol use of > 20 g/week
•Evidence of pre-existing liver or biliary disease (hepatoma, biliary tract obstruction; liver cirrhosis secondary to viral infection or immune/ congenital).
•Known or suspected hypersensitivity to GLP-1 analogues or pioglitazone.
•Receipt of any investigational medicinal product within 30 days before screening.
•Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods.
•Endocrinopathies (e.g., Cushing syndrome)
•Personal history of heart disease especially heart failure
•History of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.
•eGFR < 30
•history of heamturia or bladder cancer
•history of osteoporosis
•ALT ≥3.5 times the upper normal limit (UNL)
•Taking steroids, antipsychotics or progesterone preparations
•Uncontrolled hypertension
•Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.
•HbA1c > 10%
•Claustrophobia or unable to get MRI due to contraindications (e.g metal in the body)
•Weight > 150 kg (due to imaging trolley restrictions)

Endpoints (4)

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

MASH / liver
2
Weight & body composition
1
Glycemic / diabetes
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

change in BMI

Time frame:12 months

BMI, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Glycaemic control

Time frame:12 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

2 endpoints
Primary/protocol endpoint

change in liver stiffness in terms of kPa

Time frame:12 months

Liver stiffness (VCTE), change

change from baseline, improvement

Primary/protocol endpoint

Change in Liver fat quantification

Time frame:12 months

MRI-PDFF, % change

change from baseline, improvement

Publications (2)

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.