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Dapalost
CompletedPhase 2Exploratory Study to Investigate the Effect of Dapagliflozin and Exenatide Combined on Body Weight
A 24-week, Single Centre, Randomized, Parallel-group, Double-blind, Placebo Controlled Phase II Study With an Optional 28-week Open-label Extension to Evaluate the Efficacy on Body Weight of Dapagliflozin 10 mg Once Daily in Combination With Exenatide 2 mg Once Weekly in Obese Non-diabetic Subjects.
Lead sponsor
Asset
Exenatide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
50
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI 30-45
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Provision of signed informed consent prior to any study specific procedures.
2. Female and/or male aged 18 to 70 years with body mass index (BMI) (measured as body weight (kg)/(height (m))2) 30 to 45 kg/m2.
3. Female subjects must meet all of the following criteria:
1. Not breastfeeding
2. Negative pregnancy test result (human chorionic gonadotropin, beta subunit [beta hCG]) at Visit 1 (Enrolment) (not applicable to hysterectomized females).
3. If of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year), must practice and be willing to continue to practice one of the following highly effective birth control methods during the entire duration of the study:
4. Must practice appropriate birth control as stated above for 10 weeks after the last dose of study medication
Exclusion criteria
1. Involvement in the planning and/or conduct of the study.
2. Previous enrolment in the present study.
3. Participation in another clinical study with an Investigational Product during the last 3 months prior to Visit 1.
4. History of any clinically significant disease, disorder or condition which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
5. Previously diagnosed diabetes mellitus; or fasting P-glucose ≥7.0 mmol/L at Visit 1 confirmed by one more measurement; or P-glucose ≥11.1 mmol/L at 120 min of the oral glucose tolerance test (OGTT) at Visit 1 confirmed by one more measurement. Note: Subjects with a fasting P-glucose of ≥7.0 mmol/L at Visit 1 or ≥11.1 mmol/L at 120 min of the OGTT at Visit 1 may be offered an extra visit before Visit 2 for a second fasting P-glucose measurement. If P-glucose is still ≥7.0 mmol/L at the second measurement, the subject will be excluded.
6. Any clinically significant abnormalities in physical examination or clinical chemistry results as judged by the investigator. The following specific exclusion criteria apply to the selected Clinical Chemistry results:
1. Creatinine clearance <60 mL/min (estimated with Cockcroft-Gault formula).
2. Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN.
3. Total bilirubin (TB) >2.0 mg/dL (34.2 µmol/L).
7. Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody Immunoglobulin M (IgM), Hepatitis B surface antigen and Hepatitis C virus antibody.
8. Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
9. Acute Coronary Syndrome (ACS) within 2 months prior to Visit 1. Hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment. Acute Stroke or transient ischemic attack (TIA) within two months prior to Visit 1. Less than two months post coronary artery revascularization.
10. History of gastroparesis or pancreatitis
11. History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin cancer.
12. Body weight loss greater than 5% within 3 months prior to Visit 1.
13. Treatment with any drug known to affect body weight within the last month, e.g. systemic glucocorticoids, antipsychotics or orlistat.
14. Multiple Endocrine Neoplasia syndrome type 2.
15. Personal or family history of medullary thyroid carcinoma.
Endpoints (8)
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
4 endpointsBody weight (kg)
Time frame:From randomization to 24 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Body weight (%)
Time frame:From randomization to 24 weeks
Body weight, % change
percent change from baseline, improvement
Proportion of subjects with at least 10% reduction in weight and proportion of subjects with at least 5% reduction in weight.
Time frame:From randomization to 24 weeks
≥10% weight-loss responders
threshold achievement, improvement
Changes in body fat (%), liver fat (%), liver volume (l), total liver fat (l), visceral adipose tissue (l), subcutaneous adipose tissue (l), total adipose tissue (l) and total lean tissue (l).
Time frame:From randomization to 24 weeks
Total fat mass
change from baseline, improvement
componentsTotal fat mass, Lean mass, Liver fat content, change, Visceral fat, change, Subcutaneous fat, change
Glycemic / diabetes
1 endpoint3 h oral glucose tolerance test, frequently sampled for insulin sensitivity and secretion indices. Changes in glucose, glucagon, glycerol, free fatty acids, insulin and C-peptide.
Time frame:From enrolment to 24 weeks
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointChanges in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, diastolic blood pressure, systolic blood pressure, pulse, waist circumference and waist-hip ratio.
Time frame:From enrolment to 24 weeks
change from baseline, improvement
Safety / tolerability / PK
1 endpointAdverse events /serious adverse events, vital signs and collection of clinical chemistry/haematology parameters.
Time frame:From enrolment to 24 weeks
descriptive
componentsTreatment-emergent AEs (any), Serious AEs (any)
Other (unclassified)
1 endpointObesity-related genotypes and pharmacogenetics.
Time frame:From enrolment to 24 weeks
descriptive
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.