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Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02453711
Recruitment Status : Completed
First Posted : May 25, 2015
Results First Posted : April 17, 2020
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted globally. The aim of this trial is to investigate safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus.

Condition or disease Intervention/treatment Phase
Metabolism and Nutrition Disorder Obesity Drug: semaglutide Drug: liraglutide Drug: placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 957 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : March 30, 2017
Actual Study Completion Date : April 12, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Sema 0.05 mg
Dose 0.05 mg
Drug: semaglutide
Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.

Experimental: Sema 0.1 mg
Dose 0.05 or 0.1 mg with dose escalation every fourth week
Drug: semaglutide
Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.

Experimental: Sema 0.2 mg
Dose 0.05, 0.1 or 0.2 mg with dose escalation every fourth week
Drug: semaglutide
Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.

Experimental: Sema 0.3 mg
Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every fourth week
Drug: semaglutide
Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.

Experimental: Sema 0.4 mg
Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every fourth week
Drug: semaglutide
Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.

Experimental: Sema 0.3 mg (fast dose escalation)
Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every second week
Drug: semaglutide
Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.

Experimental: Sema 0.4 mg (fast dose escalation)
Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every second week
Drug: semaglutide
Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.

Active Comparator: Lira 3.0 mg
Dose 0.6, 1.2, 1.8, 2.4, 3.0 mg with dose escalation every week
Drug: liraglutide
Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.

Placebo Comparator: Placebo Sema 0.05 mg
Placebo arm matching active arm Sema 0.05 mg
Drug: placebo
Once-daily subcutaneous (s.c., under the skin) administration.

Placebo Comparator: Placebo Sema 0.1 mg
Placebo arm matching active arm Sema 0.1 mg
Drug: placebo
Once-daily subcutaneous (s.c., under the skin) administration.

Placebo Comparator: Placebo Sema 0.2 mg
Placebo arm matching active arm Sema 0.2 mg
Drug: placebo
Once-daily subcutaneous (s.c., under the skin) administration.

Placebo Comparator: Placebo Sema 0.3 mg
Placebo arm matching active arm Sema 0.3 mg
Drug: placebo
Once-daily subcutaneous (s.c., under the skin) administration.

Placebo Comparator: Placebo Sema 0.4 mg
Placebo arm matching active arm Sema 0.4 mg
Drug: placebo
Once-daily subcutaneous (s.c., under the skin) administration.

Placebo Comparator: Placebo Sema 0.3 mg (fast dose escalation)
Placebo arm matching active arm Sema 0.3 mg (fast dose escalation)
Drug: placebo
Once-daily subcutaneous (s.c., under the skin) administration.

Placebo Comparator: Placebo Sema 0.4 mg (fast dose escalation)
Placebo arm matching active arm Sema 0.4 mg (fast dose escalation)
Drug: placebo
Once-daily subcutaneous (s.c., under the skin) administration.

Placebo Comparator: Placebo Lira 3.0 mg
Placebo arm matching active arm Lira 3.0 mg
Drug: placebo
Once-daily subcutaneous (s.c., under the skin) administration.




Primary Outcome Measures :
  1. Relative Change in Body Weight (%) [ Time Frame: Week 0, Week 52 ]
    Relative change from baseline (week 0) in body weight was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.


Secondary Outcome Measures :
  1. Participants With Weight Loss of ≥5% of Baseline Body Weight [ Time Frame: Week 52 ]
    Presented results are percentage of participants who lost more than or equal to 5% of their baseline (week 0) body weight at week 52. Analysis of observed in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using a binary logistic regression model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.

  2. Participants With Weight Loss of ≥10% of Baseline Body Weight [ Time Frame: Week 52 ]
    Presented results are percentage of participants who lost more than or equal to 10% of their baseline (week 0) body weight at week 52. Analysis of observed in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using a binary logistic regression model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.

  3. Change in Body Weight (kg) [ Time Frame: Week 0, Week 52 ]
    Change from baseline (week 0) in body weight was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

  4. Change in Waist Circumference [ Time Frame: Week 0, Week 52 ]
    Change from baseline (week 0) in waist circumference was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline waist circumference as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

  5. Change in Waist to Hip Circumference Ratio [ Time Frame: Week 0, Week 52 ]
    Change from baseline (week 0) in waist to hip circumference ratio was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline waist to hip circumference ratio as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

  6. Change in BMI [ Time Frame: Week 0, Week 52 ]
    Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline BMI as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

  7. Change in HbA1c [ Time Frame: Week 0, Week 52 ]
    Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline HbA1c as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

  8. Change in FPG [ Time Frame: Week 0, Week 52 ]
    Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline FPG as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

  9. Change in Glycaemic Category (Normoglycaemia, Pre-diabetes, T2D) [ Time Frame: Week 0, Week 52 ]
    The categorisation of glycaemic status as described in the protocol was not aligned with the usual diagnosis criteria which require repeated testing of blood glucose to confirm the diagnosis and allows for the diagnosis to be made based on random glucose assessments and/or 2-hour glucose assessments during an oral glucose tolerance test. Therefore, data were not collected for this outcome measure.

  10. Change in SBP [ Time Frame: Week 0, Week 52 ]
    Change from baseline (week 0) in systolic blood pressure (SBP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline SBP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

  11. Change in DBP [ Time Frame: Week 0, Week 52 ]
    Change from baseline (week 0) in diastolic blood pressure (DBP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline DBP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

  12. Change in Lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides and FFA) [ Time Frame: Week 0, Week 52 ]
    Change from baseline (week 0) in lipids (total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, very low density lipoprotein (VLDL) cholesterol and triglycerides) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and respective baseline lipid value as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. Free fatty acid (FFA) results are not presented as the values were considered invalid. The shipment of the samples to be tested for FFA was not as per the requirement.

  13. Change in hsCRP [ Time Frame: Week 0, Week 52 ]
    Change from baseline (week 0) in high-sensitivity C-reactive protein (hsCRP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline hsCRP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

  14. Change in IWQoL Lite [ Time Frame: Week 0, Week 52 ]
    The planned analyses of the Impact of Weight on Quality of Life Lite (IWQoL-Lite) for Clinical Trials scores were not performed. The measure was still under development, and Novo Nordisk had not obtained a validated scoring of the instrument by the time of analysis of the trial results. Therefore, the total and subdomain scores on the IWQoL-Lite could not be provided.

  15. Change in SF-36 [ Time Frame: Week 0, Week 52 ]
    Short Form-36 (SF-36) is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at week 52. A positive change score indicates an improvement since baseline. Results are based on the in-trial observation period.

  16. Participants With Change in Concomitant Medications (Antihypertensive and Lipid-lowering Medications) [ Time Frame: Week 0, Week 52 ]
    Participants' status on receiving concomitant medication (antihypertensive and lipid-lowering medications) at week 0 (yes/no) and week 52 (decreased, no change, increased or missing) are presented. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

  17. Compliance With Nutritional Counselling [ Time Frame: Week 4-52 ]
    This outcome measure presents "nutritional compliance results" recorded at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52. Nutritional compliance was recorded on a 0 to 10 numeric rating scale (NRS), with higher scores representing better compliance.

  18. Number of AEs During the Trial [ Time Frame: Week 0-59 ]
    Adverse events (AEs) were recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

  19. Number of Hypoglycaemic Episodes During the Trial [ Time Frame: Week 0-59 ]
    Hypoglycaemic episodes were identified by either: 1) Subject reporting of symptoms of hypoglycaemia (low blood sugar) or 2) fasting plasma glucose (FPG) values ≤3.9 mmol/L (70 mg/dL) from blood sampling at site visits. Hypoglycaemic episodes were recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

  20. Number of New and Ongoing Nausea, Vomiting, Diarrhoea, and Constipation Events by Week [ Time Frame: Week 0-59 ]
    Presented results are the number of nausea, vomiting, diarrhoea, and constipation events recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

  21. Nausea: Individual Scores of Nausea Questionnaire and Severity by NRS Score [ Time Frame: Week 52 ]
    This outcome measure presents results recorded at week 52. If a participant experienced an event of nausea within 24 hours prior to a site visit, a nausea questionnaire had to be completed. Participants experiencing such events were to answer 5 different categories in the questionnaire ('duration of nausea', 'time from the latest injection of trial product to the onset of nausea', 'time from last food intake to the onset of nausea', 'nausea accompanied by vomiting (yes/no)' and 'severity of nausea (worst during episode)'). Severity of nausea was recorded on a 0 to 10 numeric rating scale (NRS), where 0 = 'No nausea' and 10 = 'Nausea as bad as it could be'. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

  22. Change in ECG [ Time Frame: Week 0, week 52 ]
    Number of participants with electrocardiogram (ECG) results, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" was recorded at baseline (week 0) and week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

  23. Change in Pulse [ Time Frame: Week 0, week 52 ]
    Change from baseline (week 0) in pulse rate was evaluated at week 52. Analysis of observed data using a mixed model for repeated measurements (MMRM) with treatment, region and sex as factors and baseline pulse as covariate, all nested within visit. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

  24. Change in Haematology: Haemoglobin [ Time Frame: Week 0, week 52 ]
    Change from baseline (week 0) in haemoglobin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

  25. Change in Haematology: Haematocrit [ Time Frame: Week 0, week 52 ]
    Change from baseline (week 0) in haematocrit was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

  26. Change in Haematology: Thrombocytes, Leucocytes and Differential Count [ Time Frame: Week 0, week 52 ]
    Change from baseline (week 0) in haematological parameters, "thrombocytes, leucocytes and differential cell count (eosinophils, neutrophils, basophils, monocytes and lymphocytes)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

  27. Change in Haematology: Erythrocytes [ Time Frame: Week 0, week 52 ]
    Change from baseline (week 0) in erythrocytes was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

  28. Change in Biochemistry: Creatinine and Bilirubin (Total) [ Time Frame: Week 0, week 52 ]
    Change from baseline (week 0) in biochemistry parameters, "creatinine and bilirubin (total)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

  29. Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP [ Time Frame: Week 0, week 52 ]
    Change from baseline (week 0) in biochemistry parameters, "creatinine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

  30. Change in Biochemistry: Urea, Sodium, Potassium and Calcium (Total) [ Time Frame: Week 0, week 52 ]
    Change from baseline (week 0) in biochemistry parameters, "urea, sodium, potassium and calcium (total)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

  31. Change in Biochemistry: Albumin [ Time Frame: Week 0, week 52 ]
    Change from baseline (week 0) in albumin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

  32. Change in Biochemistry: Calcitonin [ Time Frame: Week 0, week 52 ]
    Change from baseline (week 0) in calcitonin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

  33. Change in Biochemistry: TSH [ Time Frame: Week 0, week 52 ]
    Change from baseline (week 0) in thyroid stimulating hormone (TSH) was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

  34. Change in Mental Health Assessed by C-SSRS [ Time Frame: Week 0 and Week 4-59 ]
    Presented results are the number of participants with Columbia Suicidality Severity Rating Scale (C-SSRS) results recorded during baseline (week 0) and post baseline (week 4-52) visits. For classification of the events reported on the C-SSRS, the following categories were used: 1) Suicidal ideation, 2) Suicidal behaviour and 3) Non-suicidal self-injurious behaviour. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

  35. Change in Mental Health Assessed by PHQ-9 [ Time Frame: Week 0, week 52 ]
    Patient health questionnaire-9 (PHQ-9) was recorded at baseline (week 0) and week 52. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. On the PHQ-9, the participant rates the frequency of 9 items on a scale from 0 (not at all) to 3 (nearly every day). The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

  36. Anti-semaglutide Antibodies During and After Treatment [ Time Frame: Week 0-52 ]
    Participants were tested for anti-semaglutide antibodies from week 0 (post treatment) to week 52 (at weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52). This outcome measure is applicable only for the semaglutide treatment arms.



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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria: - 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 - Male or female, age 18 years or older at the time of signing inform consent - Body mass index (BMI) equal or above 30.0 kg/m^2 at the screening visit - At least one unsuccessful weight loss attempt per investigator judgement Exclusion Criteria: - A HbA1c (glycosylated haemoglobin) equal to or above 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus - Treatment with glucose lowering agent(s) within 90 days before screening - Screening calcitonin equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 - History of pancreatitis (acute or chronic) - Obesity induced by endocrine disorders (e.g. Cushing Syndrome) - Treatment with any medication within 90 days before screening that based on investigator's judgement may cause significant weight change - Previous surgical treatment for obesity (liposuction and/or abdominoplasty performed 1 year before screening is allowed) - History of major depressive disorder within 2 years before randomisation - Any lifetime history of a suicidal attempt - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453711


Locations
Show Show 74 study locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Layout table for investigator information
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  Study Documents (Full-Text)

Documents provided by Novo Nordisk A/S:
Study Protocol  [PDF] October 24, 2017
Statistical Analysis Plan  [PDF] October 24, 2017

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02453711    
Other Study ID Numbers: NN9536-4153
2014-001540-38 ( EudraCT Number )
U1111-1155-4660 ( Other Identifier: WHO )
First Posted: May 25, 2015    Key Record Dates
Results First Posted: April 17, 2020
Last Update Posted: April 17, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Diabetes Mellitus
Nutrition Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists