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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02453711
Other study ID # NN9536-4153
Secondary ID 2014-001540-38U1
Status Completed
Phase Phase 2
First received
Last updated
Start date October 1, 2015
Est. completion date April 12, 2017

Study information

Verified date April 2020
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 957
Est. completion date April 12, 2017
Est. primary completion date March 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
semaglutide
Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.
liraglutide
Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.
placebo
Once-daily subcutaneous (s.c., under the skin) administration.

Locations

Country Name City State
Australia Novo Nordisk Investigational Site Camperdown New South Wales
Australia Novo Nordisk Investigational Site Heidelberg Heights Victoria
Australia Novo Nordisk Investigational Site Melbourne Victoria
Australia Novo Nordisk Investigational Site Merewether New South Wales
Australia Novo Nordisk Investigational Site St Leonards New South Wales
Belgium Novo Nordisk Investigational Site Bruxelles
Belgium Novo Nordisk Investigational Site Edegem
Belgium Novo Nordisk Investigational Site Leuven
Belgium Novo Nordisk Investigational Site Liège
Belgium Novo Nordisk Investigational Site Mons
Canada Novo Nordisk Investigational Site Calgary Alberta
Canada Novo Nordisk Investigational Site Halifax Nova Scotia
Canada Novo Nordisk Investigational Site Hamilton Ontario
Canada Novo Nordisk Investigational Site Hamilton Ontario
Canada Novo Nordisk Investigational Site Moncton New Brunswick
Canada Novo Nordisk Investigational Site Montreal Quebec
Canada Novo Nordisk Investigational Site Quebec
Canada Novo Nordisk Investigational Site Surrey British Columbia
Canada Novo Nordisk Investigational Site Toronto Ontario
Germany Novo Nordisk Investigational Site Dresden
Germany Novo Nordisk Investigational Site Dresden
Germany Novo Nordisk Investigational Site Duisburg
Germany Novo Nordisk Investigational Site Leipzig
Germany Novo Nordisk Investigational Site Saint Ingbert-Oberwürzbach
Germany Novo Nordisk Investigational Site Stuttgart
Germany Novo Nordisk Investigational Site Wangen
Israel Novo Nordisk Investigational Site Haifa
Israel Novo Nordisk Investigational Site Jerusalem
Israel Novo Nordisk Investigational Site Kfar-Saba
Israel Novo Nordisk Investigational Site Petah-Tikva
Israel Novo Nordisk Investigational Site Petah-Tikva
Israel Novo Nordisk Investigational Site Tel Hashomer
Israel Novo Nordisk Investigational Site Tel-Aviv
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Novosibirsk
Russian Federation Novo Nordisk Investigational Site Penza
Russian Federation Novo Nordisk Investigational Site Saint-Petersburg
Russian Federation Novo Nordisk Investigational Site Tumen
Russian Federation Novo Nordisk Investigational Site Voronezh
Russian Federation Novo Nordisk Investigational Site Yaroslavl
Russian Federation Novo Nordisk Investigational Site Yaroslavl
United Kingdom Novo Nordisk Investigational Site Bristol
United Kingdom Novo Nordisk Investigational Site Cambridge
United Kingdom Novo Nordisk Investigational Site Glasgow
United Kingdom Novo Nordisk Investigational Site Liverpool
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site Luton
United Kingdom Novo Nordisk Investigational Site Norwich
United Kingdom Novo Nordisk Investigational Site Rotherham
United States Novo Nordisk Investigational Site Anaheim California
United States Novo Nordisk Investigational Site Arlington Virginia
United States Novo Nordisk Investigational Site Bristol Tennessee
United States Novo Nordisk Investigational Site Charleston South Carolina
United States Novo Nordisk Investigational Site Cincinnati Ohio
United States Novo Nordisk Investigational Site Crystal River Florida
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Elkridge Maryland
United States Novo Nordisk Investigational Site Golden Colorado
United States Novo Nordisk Investigational Site Greer South Carolina
United States Novo Nordisk Investigational Site Jacksonville Florida
United States Novo Nordisk Investigational Site Jacksonville Florida
United States Novo Nordisk Investigational Site Plantation Florida
United States Novo Nordisk Investigational Site Portland Oregon
United States Novo Nordisk Investigational Site Richmond Virginia
United States Novo Nordisk Investigational Site Rochester New York
United States Novo Nordisk Investigational Site Round Rock Texas
United States Novo Nordisk Investigational Site San Diego California
United States Novo Nordisk Investigational Site Sugar Land Texas
United States Novo Nordisk Investigational Site Wadsworth Ohio
United States Novo Nordisk Investigational Site Washington District of Columbia
United States Novo Nordisk Investigational Site Waterbury Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Germany,  Israel,  Russian Federation,  United Kingdom, 

References & Publications (2)

Kolotkin RL, Williams VSL, Ervin CM, Williams N, Meincke HH, Qin S, von Huth Smith L, Fehnel SE. Validation of a new measure of quality of life in obesity trials: Impact of Weight on Quality of Life-Lite Clinical Trials Version. Clin Obes. 2019 Jun;9(3):e12310. doi: 10.1111/cob.12310. Epub 2019 Apr 16. — View Citation

O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double- — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Relative Change in Body Weight (%) 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. Week 0, Week 52
Secondary Participants With Weight Loss of =5% of Baseline Body Weight 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. Week 52
Secondary Participants With Weight Loss of =10% of Baseline Body Weight 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. Week 52
Secondary Change in Body Weight (kg) 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. Week 0, Week 52
Secondary Change in Waist Circumference 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. Week 0, Week 52
Secondary Change in Waist to Hip Circumference Ratio 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. Week 0, Week 52
Secondary Change in BMI 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. Week 0, Week 52
Secondary Change in HbA1c 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. Week 0, Week 52
Secondary Change in FPG 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. Week 0, Week 52
Secondary Change in Glycaemic Category (Normoglycaemia, Pre-diabetes, T2D) 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. Week 0, Week 52
Secondary Change in SBP 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. Week 0, Week 52
Secondary Change in DBP 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. Week 0, Week 52
Secondary Change in Lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides and FFA) 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. Week 0, Week 52
Secondary Change in hsCRP 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. Week 0, Week 52
Secondary Change in IWQoL Lite 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. Week 0, Week 52
Secondary Change in SF-36 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. Week 0, Week 52
Secondary Participants With Change in Concomitant Medications (Antihypertensive and Lipid-lowering Medications) 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. Week 0, Week 52
Secondary Compliance With Nutritional Counselling 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. Week 4-52
Secondary Number of AEs During the Trial 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. Week 0-59
Secondary Number of Hypoglycaemic Episodes During the Trial 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. Week 0-59
Secondary Number of New and Ongoing Nausea, Vomiting, Diarrhoea, and Constipation Events by Week 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. Week 0-59
Secondary Nausea: Individual Scores of Nausea Questionnaire and Severity by NRS Score 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. Week 52
Secondary Change in ECG 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. Week 0, week 52
Secondary Change in Pulse 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. Week 0, week 52
Secondary Change in Haematology: Haemoglobin 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. Week 0, week 52
Secondary Change in Haematology: Haematocrit 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. Week 0, week 52
Secondary Change in Haematology: Thrombocytes, Leucocytes and Differential Count 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. Week 0, week 52
Secondary Change in Haematology: Erythrocytes 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. Week 0, week 52
Secondary Change in Biochemistry: Creatinine and Bilirubin (Total) 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. Week 0, week 52
Secondary Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP 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. Week 0, week 52
Secondary Change in Biochemistry: Urea, Sodium, Potassium and Calcium (Total) 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. Week 0, week 52
Secondary Change in Biochemistry: Albumin 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. Week 0, week 52
Secondary Change in Biochemistry: Calcitonin 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. Week 0, week 52
Secondary Change in Biochemistry: TSH 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. Week 0, week 52
Secondary Change in Mental Health Assessed by C-SSRS 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. Week 0 and Week 4-59
Secondary Change in Mental Health Assessed by PHQ-9 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. Week 0, week 52
Secondary Anti-semaglutide Antibodies During and After Treatment 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. Week 0-52
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