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| ID | Type | Description | Link |
|---|---|---|---|
| Universal Trial Number | Registry Identifier | U1111-1249-8833 |
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low recruitment
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This randomized study evaluates the effect of subcutaneous semaglutide /in combination with lifestyle counseling in patients with type 2 diabetes mellitus (T2DM), overweight/obesity, and stage 4-5 chronic kidney disease (CKD) or dialysis-dependent end-stage kidney disease (ESKD) on patients' eligibility for kidney transplantation at the end of 9 months.
Transplant policies regarding listing consider uncontrolled diabetes and severe obesity to be contraindications though there is great variability for exact BMI (35-45 kg/m2) and A1c (9-10%) thresholds for listing by center. Glucagon-lowering peptide-1 receptor agonists (GLP-1 RAs) offer great promise in this population as they have been shown to reduce weight, central adiposity, A1c, and risk of cardiovascular outcomes with similar effects in patients with and without CKD.
In this double-blind, placebo-controlled randomized controlled trial, the investigators will evaluate the effect of subcutaneous semaglutide 1.34 mg/ml (up to 1.0 mg per week) in combination with lifestyle counseling in patients with T2DM, overweight/obesity, and stage 4-5 CKD or dialysis-dependent ESKD on patients' eligibility for kidney transplantation in terms of diabetes control (A1c <9%) and obesity (BMI <35 kg/m2 or 35-40 kg/m2 with waist circumference <120 cm) at the end of 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Active Comparator | This arm will receive semaglutide. |
|
| Placebo | Placebo Comparator | This arm will receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution | Drug | Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney Transplant Eligibility | Proportion either listed for kidney transplant at 9 months or meeting the following kidney transplant candidacy criteria for A1c (<9%) and obesity (BMI <35 kg/m2 or BMI 35-40 kg/m2 with waist circumference <120 cm) | Ascertained at the end of 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c (HgbA1c) | HgbA1c will be collected using routine procedures and measured on the same day at the central Geisinger laboratory by Turbidimetric inhibition immunoassay. | From baseline to 9 months |
| Change in BMI |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Low-Density Lipoprotein (LDL) | Collected at a Geisinger lab using routine procedures and measured on the same day at the central Geisinger laboratory by spectrophotometry. | Baseline to 9 months |
| Change in Triglycerides |
Inclusion Criteria:
- Age ≥ 18 years
- BMI 25-45 kg/m2
- T2DM
- Advanced CKD* (last eGFR <30 ml/min/1.73m2 in EHR or ESKD on dialysis prior to screening) or stage G3B/A2-3 CKD (eGFR 30 to <45 ml/min/1.73m2 with albumin/creatinine ratio >30 mg/g).
- Fulfill kidney transplant listing criteria except for one or more of the following reasons (1: uncontrolled diabetes [A1c ≥9%); 2: severe obesity (BMI ≥ 40 kg/m2 or BMI 35-40 kg/m2 with waist circumference >120 cm). See exclusion criteria for general contraindications used for transplant listing used by majority of U.S. transplant centers].
- Ability to provide informed consent before any trial-related activities
- Access to a telephone
Exclusion Criteria (General contraindications used for transplant listing used by majority of U.S. transplant centers)
- Active malignancy
- History of pancreatitis
- Active substance abuse
- Severe COPD
- Pulmonary fibrosis
- Symptomatic angina or recent myocardial infarction within 6 months
- Severe peripheral vascular disease
- Cirrhosis
- New York Health Association (NYHA) Class III-IV congestive heart failure
- Severe cognitive impairment
- Drug addiction
- History of non-adherence to therapy
- Active infection
- Expected life expectancy < 5 years
Additional exclusion criteria
- Type 1 diabetes mellitus
- History of diabetic ketoacidosis within the last 12 months
- Planning on undergoing bariatric surgery in next 9 months.
- Pregnant, breast-feeding, or planned pregnancy prior to the end of participation or not using adequate contraceptive measures
- Self-reported average consumption of > 21 alcoholic beverages per week or binge drinking
- Psychiatric hospitalization in past year
- Principal investigator discretion (i.e. concerns about safety, compliance)
- Known or suspected allergy to trial medication
- Previous participation (i.e. randomized) in this trial
- Use of GLP1-RA or pramlintide within 90 days prior to screening
- Use of metformin (contraindicated with eGFR < 30 ml/min/1.73m2)
- Use of DPP-4 inhibitors within 30 days prior to screening
- Personal or family history of medullary thyroid cancer, multiple endocrine neoplasia types 2A and 2B syndrome
- Last hemoglobin A1c ≥ 12% or A1c <6% (to avoid risk of hypoglycemia) prior to screening
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| Name | Affiliation | Role |
|---|---|---|
| Alex R Chang, MD, MS | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Medical Center | Danville | Pennsylvania | 17821 | United States | ||
| Geisinger Wyoming Valley |
Not provided
Data will become available at the time of publication of the main trial results and will be publicly available indefinitely.
The deidentified IPD will be publicly available without restrictions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Semaglutide | This arm will receive semaglutide. Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2022 |
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This is a placebo-controlled double-blind clinical trial. Study investigators and participants will be blinded to treatment allocation.
|
| Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution | Drug | Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation. |
|
|
Weight will be measured at each study visit in light clothing without shoes by trained, certified staff using a calibrated, digital scale. Scales will be calibrated annually. Height will be measured at the initial study visit to the nearest 0.1 cm using a calibrated, wall-mounted stadiometer without shoes on a firm, level surface, with head in the horizontal plane.
| From baseline to 9 months |
| Change in Waist Circumference | Waist circumference will be measured at each study visit to the nearest 0.1 cm using a Gulick II tape measure. | From baseline to 9 months |
| Change in Waist-to-hip Ratio | Hip circumference will also be measured to the nearest 0.1 cm using a Gulick II tape measure, and waist-to-hip ratio will be calculated. | From baseline to 9 months |
| Change in Body Fat Percentage | Measured using bioelectrical impedance analysis | From baseline to 9 months |
| New Activation on the Transplant List | Proportion of participants who were newly added to a transplant list during study period. Assessed by Geisinger kidney transplant committee (blinded to randomization assignment, independent of investigators) | Assessed at end of 9 months |
| Receipt of Kidney Transplant | Confirmed by review of electronic health record (EHR) | Assessed at end of 9 months |
Collected at a Geisinger lab using routine procedures and measured on the same day at the central Geisinger laboratory by spectrophotometry.
| Baseline to 9 months |
| Change in Systolic Blood Pressure | Automated office blood pressure (AOBP) will be measured (attended) using the OMRON 907-XL machine, with a 5-minute rest period in the seated position, followed by 3 measurements separated by 1-minute time intervals by trained research staff. Mid-arm circumference will be measured, and a cuff of appropriate size will be identified and the same size cuff will used for both visits. | Baseline to 9 months |
| Change in Diastolic Blood Pressure | Automated office blood pressure (AOBP) will be measured (attended) using the OMRON 907-XL machine, with a 5-minute rest period in the seated position, followed by 3 measurements separated by 1-minute time intervals by trained research staff. Mid-arm circumference will be measured, and a cuff of appropriate size will be identified and the same size cuff will used for both visits. | Baseline to 9 months |
| Change in Albuminuria Among Subset of Participants Without End-stage Kidney Disease | Testing at the central Geisinger laboratory, using immunoturbidimetry (albumin) and Jaffe/Enzymatic (Urine Creatinine) | Baseline to 9 months |
| Change in Estimated Glomerular Filtration (eGFR) Rate Among Subset of Participants Without End-stage Kidney Disease | Testing at central Geisinger lab; Creatinine-based CKD-EPI equation | Baseline to 9 months |
| All-cause Hospitalizations | Collected using Geisinger EHR data | Entire 9-month study period |
| Cardiovascular Disease (CVD) Events | Collected using Geisinger EHR data using ICD codes for CVD-related hospitalizations | Entire 9-month study period |
| Proportion Experiencing Doubling of Creatinine or End-stage Kidney Disease | Collected using Geisinger EHR data using ICD codes | Entire 9-month study period |
| Proportion Experiencing Death | Collected using Geisinger EHR data | Entire 9-month study period |
| Proportion Experiencing Gastrointestinal Disorders | Assessed at each study visit | Entire 9-month study period |
| Proportion Experiencing Gallbladder Disorders | Assessed at each study visit | Entire 9-month study period |
| Proportion Experiencing Neoplasms | Assessed at each study visit | Entire 9-month study period |
| Proportion Experiencing Hepatic Events | Assessed at each study visit | Entire 9-month study period |
| Proportion Experiencing Allergic Reactions | Assessed at each study visit | Entire 9-month study period |
| Proportion Experiencing Injection-site Reactions | Assessed at each study visit | Entire 9-month study period |
| Proportion Experiencing Hypoglycemia Events | Assessed at each study visit | Entire 9-month study period |
| Proportion Experiencing Acute Pancreatitis Events | Assessed at each study visit | Entire 9-month study period |
| Wilkes-Barre |
| Pennsylvania |
| 18702 |
| United States |
| Placebo |
This arm will receive placebo. Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution: Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Semaglutide | This arm will receive semaglutide. Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week. |
| BG001 | Placebo | This arm will receive placebo. Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution: Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Hemoglobin A1c | Mean | Standard Deviation | Percentage of glycosylated hemoglobin |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Waist circumference | Mean | Standard Deviation | cm |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Kidney Transplant Eligibility | Proportion either listed for kidney transplant at 9 months or meeting the following kidney transplant candidacy criteria for A1c (<9%) and obesity (BMI <35 kg/m2 or BMI 35-40 kg/m2 with waist circumference <120 cm) | Posted | Count of Participants | Participants | Ascertained at the end of 9 months |
|
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| ||||||||||||||||||||||||||||||
| Secondary | Change in Hemoglobin A1c (HgbA1c) | HgbA1c will be collected using routine procedures and measured on the same day at the central Geisinger laboratory by Turbidimetric inhibition immunoassay. | Posted | Mean | Standard Deviation | Percentage of glycosylated hemoglobin | From baseline to 9 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in BMI | Weight will be measured at each study visit in light clothing without shoes by trained, certified staff using a calibrated, digital scale. Scales will be calibrated annually. Height will be measured at the initial study visit to the nearest 0.1 cm using a calibrated, wall-mounted stadiometer without shoes on a firm, level surface, with head in the horizontal plane. | Posted | Mean | Standard Deviation | kg/m^2 | From baseline to 9 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in Waist Circumference | Waist circumference will be measured at each study visit to the nearest 0.1 cm using a Gulick II tape measure. | Posted | Mean | Standard Deviation | cm | From baseline to 9 months |
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| ||||||||||||||||||||||||||||||
| Secondary | Change in Waist-to-hip Ratio | Hip circumference will also be measured to the nearest 0.1 cm using a Gulick II tape measure, and waist-to-hip ratio will be calculated. | Posted | Mean | Standard Deviation | cm/cm | From baseline to 9 months |
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| ||||||||||||||||||||||||||||||
| Secondary | Change in Body Fat Percentage | Measured using bioelectrical impedance analysis | Posted | Mean | Standard Deviation | Body fat percentage | From baseline to 9 months |
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| Secondary | New Activation on the Transplant List | Proportion of participants who were newly added to a transplant list during study period. Assessed by Geisinger kidney transplant committee (blinded to randomization assignment, independent of investigators) | Posted | Count of Participants | Participants | Assessed at end of 9 months |
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| Secondary | Receipt of Kidney Transplant | Confirmed by review of electronic health record (EHR) | Posted | Count of Participants | Participants | Assessed at end of 9 months |
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| Other Pre-specified | Change in Low-Density Lipoprotein (LDL) | Collected at a Geisinger lab using routine procedures and measured on the same day at the central Geisinger laboratory by spectrophotometry. | One patient in the placebo arm did not complete follow-up LDL measurement, and thus there is 1 less participant analyzed in the placebo arm. | Posted | Mean | Standard Deviation | mg/dL | Baseline to 9 months |
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| Other Pre-specified | Change in Triglycerides | Collected at a Geisinger lab using routine procedures and measured on the same day at the central Geisinger laboratory by spectrophotometry. | Not Posted | Baseline to 9 months | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Systolic Blood Pressure | Automated office blood pressure (AOBP) will be measured (attended) using the OMRON 907-XL machine, with a 5-minute rest period in the seated position, followed by 3 measurements separated by 1-minute time intervals by trained research staff. Mid-arm circumference will be measured, and a cuff of appropriate size will be identified and the same size cuff will used for both visits. | Not Posted | Baseline to 9 months | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Diastolic Blood Pressure | Automated office blood pressure (AOBP) will be measured (attended) using the OMRON 907-XL machine, with a 5-minute rest period in the seated position, followed by 3 measurements separated by 1-minute time intervals by trained research staff. Mid-arm circumference will be measured, and a cuff of appropriate size will be identified and the same size cuff will used for both visits. | Not Posted | Baseline to 9 months | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Albuminuria Among Subset of Participants Without End-stage Kidney Disease | Testing at the central Geisinger laboratory, using immunoturbidimetry (albumin) and Jaffe/Enzymatic (Urine Creatinine) | Not Posted | Baseline to 9 months | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Estimated Glomerular Filtration (eGFR) Rate Among Subset of Participants Without End-stage Kidney Disease | Testing at central Geisinger lab; Creatinine-based CKD-EPI equation | Not Posted | Baseline to 9 months | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | All-cause Hospitalizations | Collected using Geisinger EHR data | Not Posted | Entire 9-month study period | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Cardiovascular Disease (CVD) Events | Collected using Geisinger EHR data using ICD codes for CVD-related hospitalizations | Not Posted | Entire 9-month study period | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Proportion Experiencing Doubling of Creatinine or End-stage Kidney Disease | Collected using Geisinger EHR data using ICD codes | Not Posted | Entire 9-month study period | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Proportion Experiencing Death | Collected using Geisinger EHR data | Not Posted | Entire 9-month study period | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Proportion Experiencing Gastrointestinal Disorders | Assessed at each study visit | Not Posted | Entire 9-month study period | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Proportion Experiencing Gallbladder Disorders | Assessed at each study visit | Not Posted | Entire 9-month study period | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Proportion Experiencing Neoplasms | Assessed at each study visit | Not Posted | Entire 9-month study period | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Proportion Experiencing Hepatic Events | Assessed at each study visit | Not Posted | Entire 9-month study period | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Proportion Experiencing Allergic Reactions | Assessed at each study visit | Not Posted | Entire 9-month study period | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Proportion Experiencing Injection-site Reactions | Assessed at each study visit | Not Posted | Entire 9-month study period | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Proportion Experiencing Hypoglycemia Events | Assessed at each study visit | Not Posted | Entire 9-month study period | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Proportion Experiencing Acute Pancreatitis Events | Assessed at each study visit | Not Posted | Entire 9-month study period | Participants |
9 months
Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Semaglutide | This arm will receive semaglutide. Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week. | 0 | 7 | 2 | 7 | 5 | 7 |
| EG001 | Placebo | This arm will receive placebo. Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution: Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation. | 0 | 8 | 3 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Cardiac disorders | Non-systematic Assessment |
| ||
| Uremia | Renal and urinary disorders | Non-systematic Assessment |
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| Hypertensive urgency | Cardiac disorders | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Bacteremia | Infections and infestations | Non-systematic Assessment |
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| Appendicitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia events | Endocrine disorders | Systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
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| Gallbladder disorders | Hepatobiliary disorders | Systematic Assessment |
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| Neoplasms | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Hepatic events | Hepatobiliary disorders | Systematic Assessment |
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| Allergic reactions | Immune system disorders | Systematic Assessment |
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| Injection-site reactions | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Acute pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| Anemia or bleeding disorder | Blood and lymphatic system disorders | Non-systematic Assessment |
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| shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Foot ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hypertension | Cardiac disorders | Non-systematic Assessment |
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The study was terminated prematurely by the funder due to slow recruitment.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander Chang | Geisinger | 570-271-8026 | achang@geisinger.edu |
| Jan 11, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D009765 | Obesity |
| D009767 | Obesity, Morbid |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
Not provided
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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