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D-LIFT
CompletedPhase NAEffect of Dulaglutide on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease
Effect of Dulaglutide on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial
Lead sponsor
Asset
Dulaglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
60
actual
Study population
MASH / NAFLD / liver fibrosis, Type 2 diabetes
Key I/E criterion
•HbA1c 7-10%
Primary endpoint
•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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. A man or woman, 20 years of age or above with the diagnosis of type 2 diabetes for at least 3 months who meets all of the following two criteria:
1. On standard anti-diabetic agents (metformin, DPP-4 inhibitors, sulphonylureas or insulin, in any combination) with an HbA1c of ≤ 7.0% and ≥10.0% (≤53 and ≥86 mmol/mol) at screening
2. Have documented hepatic steatosis (MRI-PDFF >6%) on screening MRI-PDFF
2. Subjects must be medically stable on the basis of medical history, physical examination and laboratory investigations.
3. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
4. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and are willing to participate in the study
Exclusion criteria
1. History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
2. History of brittle or labile glycemic control, with widely varying glucose measurements by FPG or SMBG such that stable glucose control over the treatment period would be unlikely.
3. History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 3 years before Screening, or an Alcohol Use Disorders Identification Test (AUDIT) with a score ≥8, or alcohol consumption of more than 20 g per day in the case of women and more than 30 g per day in the case of men for at least three consecutive months during the previous 5 years.
4. Thyroid stimulating hormone (TSH) value that is either < 0.45 mIU/L or >10 mIU/L at Screening.
Note: Subjects on thyroid hormone replacement therapy must be on a stable dose and dosing regimen for at least 4 weeks prior to enrollment.
5. Use of a PPARγ agonist [e.g., a thiazolidinedione (pioglitazone], an SGLT2 inhibitor (e.g., canagliflozin, empagliflozin) or another GLP-1 receptor agonist (e.g., liraglutide) within 24 weeks before the enrollment.
6. BMI ≥23 kg/m2 or ≤40 kg/m2.
7. Ongoing eating disorder, or a significant weight loss or weight gain within 12 weeks before the Screening visit, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, based on subject's report.
8. Use of weight loss medication (prescription and/or over-the-counter) within 3 months prior to Screening or have participated in a weight loss/diet program within 12 months prior to Screening.
9. Renal disease that required treatment with immunosuppressive therapy or a history of dialysis or renal transplant.
10. Myocardial infarction, unstable angina, pulmonary hypertension, revascularisation procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 3 months before Screening, or revascularisation procedure is planned, or subject has a history of New York Heart Association (NYHA) Class III-IV cardiac disease.
11. History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
12. Use of vitamin E within 3 months before screening.
13. History of prior bariatric (e.g., Roux-en-Y gastric bypass) or other major upper gastrointestinal surgical procedure (including gastric resection).
14. History of diabetic gastroparesis (or symptoms suggestive of this disorder, including postprandial bloating or vomiting), malabsorption, inflammatory bowel disease, or any other chronic, clinically important gastrointestinal disorder.
15. Estimated glomerular filtration rate (eGFR) <65 mL/min/1•73 m2 using the Modification of Diet in Renal Disease Study (MDRD) equation.
16. Subjects with a history of having or possibly having metallic material in the body or any contraindication for a MR examination.
17. Screening fasting serum triglycerides ≥600 mg/dL (6•74 mmol/L).
18. Claustrophobia, or anxiety related to previous negative experiences with magnetic resonance imaging procedures or if the subject is unwilling to participate in magnetic resonance imaging procedures.
19. Clinically important hematologic disorder (e.g., symptomatic anemia, proliferative bone marrow disorder, thrombocytopenia) at Screening.
20. History of human immunodeficiency virus (HIV) antibody positive at Screening.
21. Major surgery (e.g., requiring general anaesthesia) within 12 weeks before Screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study.
22. Contraindications to the use of dulaglutide (per DULAGLUTIDE US Prescribing Information).
23. Current use of a corticosteroid medication or immunosuppressive agent, or likely to require treatment with a corticosteroid medication or an immunosuppressive agent.
Note: Subjects using inhaled, intranasal, intra-articular, or topical corticosteroids, or corticosteroids in therapeutic replacement doses may participate.
24. Pregnancy or women breastfeeding or planning to become pregnant while enroled in this study.
25. History of significant cardiac, vascular, pulmonary, renal, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
26. Use of drugs known to cause hepatic steatosis like methotrexate
Endpoints (7)
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
6 endpointsChange in liver fat
Time frame:Baseline to 24 weeks
MRI-PDFF, % change
percent change from baseline, improvement
Change in Biochemical Markers
Time frame:Basline to 24 weeks
AST, change
change from baseline, improvement
LOINC 1920-8
Change in Fibroscan Parameters
Time frame:Basline to 24 weeks
Liver stiffness (VCTE), change
change from baseline, improvement
Change in Fibroscan Parameters
Time frame:Basline to 24 weeks
change from baseline, improvement
Change in Biochemical Markers
Time frame:Baseline to 24 weeks
ALT, change
change from baseline, improvement
LOINC 1742-6
Change in Biochemical Markers
Time frame:Baseline to 24 weeks
γ-GT, change
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointchange in cardiometabolic markers
Time frame:Basline to 24 weeks
change from baseline, improvement
Publications (12)
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
- Diabetologia2020 Nov (month)PMID32865597doi:10.1007/s00125-020-05265-7via clinicaltrials gov reference derived + pubmed nct search
- The Journal of clinical endocrinology and metabolism2017 Feb 1PMID27732328doi:10.1210/jc.2016-2775via CT.gov reference
- Lancet (London, England)2014 Oct 11PMID25018121doi:10.1016/S0140-6736(14)60976-4via CT.gov reference
- Alimentary pharmacology & therapeutics2013 Mar (month)PMID23383649doi:10.1111/apt.12237via CT.gov reference
- Alimentary pharmacology & therapeutics2012 Jul (month)PMID22554256doi:10.1111/j.1365-2036.2012.05121.xvia CT.gov reference
- Journal of magnetic resonance imaging : JMRI2011 Oct (month)PMID22025886doi:10.1002/jmri.22775via CT.gov reference
Provenance
Sources
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.