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Dapalost

CompletedPhase 2

Exploratory 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

Uppsala University

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

NCT IDNCT02313220
Org study IDD1690L00016
Secondary ID2014-003432-39

Timeline

Milestones

Study first posted2014-12-09estimated
Last update posted2016-11-17estimated
Study start2014-12 (month precision)
Primary completion2016-03actual (month precision)
Study completion2016-03actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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:

Diaphragm or partner use of condom in combination with combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
Oral
Intravaginal
Transdermal
Diaphragm or partner use of condom in combination with progestogen-only hormonal contraception associated with inhibition of ovulation:
Oral
Injectable
Implantable
Placement of an intrauterine device
Placement of an intrauterine hormone-releasing system
Bilateral tubal occlusion
Vasectomised partner (provided that the partner is the sole sexual partner of the female subject and that the vasectomised partner has received medical assessment of the surgical success)
Sexual abstinence (defined as refraining from heterosexual intercourse)

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
Glycemic / diabetes
1
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1
Other (unclassified)
1

Weight & body composition

4 endpoints
Primary/protocol endpoint

Body weight (kg)

Time frame:From randomization to 24 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Body weight (%)

Time frame:From randomization to 24 weeks

Body weight, % change

percent change from baseline, improvement

Other/protocol endpoint

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

Other/protocol endpoint

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 endpoint
Other/protocol endpoint/low confidence

3 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 endpoint
Other/protocol endpoint

Changes 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 endpoint
Other/protocol endpoint

Adverse 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 endpoint
Other/protocol endpoint

Obesity-related genotypes and pharmacogenetics.

Time frame:From enrolment to 24 weeks

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.