Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity (STEP 5)

• ClinicalTrials.gov Identifier: NCT03693430
• Recruitment Status: Completed
• First Posted: October 3, 2018
• Results First Posted: March 23, 2022
• Last Update Posted: July 6, 2023
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Study Description

Brief Summary:

This study will look at the change in body weight from the start to the end of the study. Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking "dummy" medicine. In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 2 years. The participants will have 19 clinic visits and 15 phone calls with the study doctor.

Condition or disease	Intervention/treatment	Phase
Overweight; Obesity	Drug: Semaglutide; Drug: Placebo (Semaglutide)	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 304 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Two-year Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity
• Actual Study Start Date: October 5, 2018
• Actual Primary Completion Date: January 29, 2021
• Actual Study Completion Date: March 23, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Semaglutide; Participants will receive semaglutide 2.4 mg during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.	Drug: Semaglutide; Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks
Placebo Comparator: Placebo; Participants will receive placebo (semaglutide) during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.	Drug: Placebo (Semaglutide); S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks

Outcome Measures

Primary Outcome Measures :

1. Percentage Change From Baseline (Week 0) to Week 104 in Body Weight [ Time Frame: From Baseline (Week 0) to Week 104 ]
   Percentage change in body weight for both in-trial and on-treatment observation period from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
2. Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% [ Time Frame: At Week 104 ]
   Number of participants who achieved greater than or equal to (>=) 5% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=5% weight loss, whereas 'No' infers the number of participants who have not achieved >=5% weight loss. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).

Secondary Outcome Measures :

1. Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10% [ Time Frame: At Week 104 ]
   Number of participants who achieved >=10% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=10% weight loss, whereas 'No' infers the number of participants who have not achieved >=10% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
2. Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15% [ Time Frame: At Week 104 ]
   Number of participants who achieved >=15% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=15% weight loss, whereas 'No' infers the number of participants who have not achieved >=15% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
3. Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20% [ Time Frame: At Week 104 ]
   Number of participants who achieved >=20% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=20% weight loss, whereas 'No' infers the number of participants who have not achieved >=20% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
4. Change From Baseline (Week 0) to Week 104 in Waist Circumference [ Time Frame: From Baseline (Week 0) to Week 104 ]
   Change in waist circumference from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
5. Change From Baseline (Week 0) to Week 104 in Body Weight (kg) [ Time Frame: From Baseline (Week 0) to Week 104 ]
   Change in body weight from baseline (week 0) to week 104 in kilogram (kg) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
6. Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI) [ Time Frame: From Baseline (Week 0) to Week 104 ]
   Change in BMI from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
7. Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure [ Time Frame: From Baseline (Week 0) to Week 104 ]
   Change in systolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
8. Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure [ Time Frame: From Baseline (Week 0) to Week 104 ]
   Change in diastolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
9. Change in Total Cholesterol-ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
   Change in total cholesterol from baseline (week 0) to week 104 measured in milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
10. Change in High Density Lipoprotein (HDL) Cholesterol-ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in HDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
11. Change in Low Density Lipoprotein (LDL) Cholesterol-ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in LDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
12. Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in VLDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
13. Change in Free Fatty Acids-ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in free fatty acids from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
14. Change in Triglycerides-ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in triglycerides from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
15. Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in hsCRP from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
16. Change in Glycated Haemoglobin (HbA1c) (Percent [%]) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in HbA1c from baseline (week 0) to week 104 in % is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
17. Change From Baseline (Week 0) to Week 104 in HbA1c (mmol/Mol) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in HbA1c from baseline (week 0) to week 104 in millimole per mole (mmol/mol) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
18. Change From Baseline (Week 0) to Week 104 in Fasting Plasma Glucose (FPG) (mmol/L) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in FPG from baseline (week 0) to week 104 in millimoles per liter (mmol/L) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
19. Change From Baseline (Week 0) to Week 104 in FPG (mg/dL) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in FPG from baseline (week 0) to week 104 in mg/dL is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
20. Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in fasting serum insulin from baseline (week 0) to week 104 measured in picomole per liter (pmol) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
21. Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in fasting serum insulin from baseline (week 0) to week 104 measured in milli-international units per milliliter (mIU/mL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
22. Percentage Change From Baseline (Week 0) to Week 52 in Body Weight [ Time Frame: From Baseline (Week 0) to Week 52 ]
    Percentage change in body weight from baseline (week 0) to week 52 is presented.
23. Change From Baseline (Week 0) to Week 52 in Body Weight (kg) [ Time Frame: From Baseline (Week 0) to Week 52 ]
    Change in body weight from baseline (week 0) to week 52 in kg is presented.
24. Change From Baseline (Week 0) to Week 52 in Body Mass Index (BMI) [ Time Frame: From Baseline (Week 0) to Week 52 ]
    Change in BMI from baseline (week 0) to week 52 is presented.
25. Change From Baseline (Week 0) to Week 52 in Waist Circumference [ Time Frame: From Baseline (Week 0) to Week 52 ]
    Change in waist circumference from baseline (week 0) to week 52 is presented.
26. Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% [ Time Frame: At Week 52 ]
    Number of participants who achieved >=5% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=5% weight loss, whereas 'No' infers the number of participants who have not achieved >=5% weight loss.
27. Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10% [ Time Frame: At Week 52 ]
    Number of participants who achieved >=10% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=10% weight loss, whereas 'No' infers the number of participants who have not achieved >=10% weight loss.
28. Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15% [ Time Frame: At Week 52 ]
    Number of participants who achieved >=15% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=15% weight loss, whereas 'No' infers the number of participants who have not achieved >=15% weight loss.
29. Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20% [ Time Frame: At Week 52 ]
    Number of participants who achieved >=20% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=20% weight loss, whereas 'No' infers the number of participants who have not achieved >=20% weight loss.
30. Number of Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From Baseline (Week 0) to Week 111 ]
    An adverse event (AE) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to treatment. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as >7 consecutive missed doses (corresponding to >7 weeks off-treatment).
31. Number of Serious Adverse Events (SAEs) [ Time Frame: From Baseline (Week 0) to Week 111 ]
    A SAE was defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 0 to week 111 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as >7 consecutive missed doses (corresponding to >7 weeks off-treatment).
32. Change From Baseline (Week 0) to Week 104 in Pulse [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in pulse from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
33. Change From Baseline (Week 0) to Week 104 in Amylase [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in amylase from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
34. Change From Baseline (Week 0) to Week 104 in Lipase [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in lipase from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
35. Change From Baseline (Week 0) to Week 104 in Calcitonin [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in calcitonin from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male or female, age more than or equal to 18 years at the time of signing informed consent
• Body mass index (BMI) more than or equal to 30 kg/m^2 or more than or equal to 27 kg/m^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
• History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion criteria:

• HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
• A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Contacts and Locations

Locations

United States, Alabama

Novo Nordisk Investigational Site

Birmingham, Alabama, United States, 35222

United States, California

Novo Nordisk Investigational Site

Los Angeles, California, United States, 90057

United States, Colorado

Novo Nordisk Investigational Site

Aurora, Colorado, United States, 80045

Novo Nordisk Investigational Site

Golden, Colorado, United States, 80401

United States, Connecticut

Novo Nordisk Investigational Site

Waterbury, Connecticut, United States, 06708

United States, Florida

Novo Nordisk Investigational Site

Jacksonville, Florida, United States, 32205

Novo Nordisk Investigational Site

Ocala, Florida, United States, 34471

United States, Missouri

Novo Nordisk Investigational Site

Saint Peters, Missouri, United States, 63303

United States, Montana

Novo Nordisk Investigational Site

Butte, Montana, United States, 59701

United States, New York

Novo Nordisk Investigational Site

Albany, New York, United States, 12203

Novo Nordisk Investigational Site

Rochester, New York, United States, 14609

United States, Tennessee

Novo Nordisk Investigational Site

Kingsport, Tennessee, United States, 37660

United States, Texas

Novo Nordisk Investigational Site

Austin, Texas, United States, 78731

Novo Nordisk Investigational Site

Round Rock, Texas, United States, 78681

United States, Virginia

Novo Nordisk Investigational Site

Arlington, Virginia, United States, 22206

Canada, British Columbia

Novo Nordisk Investigational Site

Surrey, British Columbia, Canada, V3Z 2N6

Canada, New Brunswick

Novo Nordisk Investigational Site

Moncton, New Brunswick, Canada, E1G 1A7

Canada, Nova Scotia

Novo Nordisk Investigational Site

Halifax, Nova Scotia, Canada, B3H 1V7

Canada, Ontario

Novo Nordisk Investigational Site

Hamilton, Ontario, Canada, L8L 5G8

Novo Nordisk Investigational Site

Hamilton, Ontario, Canada, L8M 1K7

Novo Nordisk Investigational Site

Toronto, Ontario, Canada, M4G 3E8

Novo Nordisk Investigational Site

Toronto, Ontario, Canada, M4P 1P2

Canada, Quebec

Novo Nordisk Investigational Site

Montreal, Quebec, Canada, H4N 2W2

Canada

Novo Nordisk Investigational Site

Quebec, Canada, G1V 4G2

Hungary

Novo Nordisk Investigational Site

Budapest, Hungary, 1132

Novo Nordisk Investigational Site

Budapest, Hungary, 1152

Novo Nordisk Investigational Site

Budapest, Hungary, H-1134

Novo Nordisk Investigational Site

Debrecen, Hungary, 4043

Novo Nordisk Investigational Site

Komarom, Hungary, 2900

Novo Nordisk Investigational Site

Szekszárd, Hungary, 7100

Italy

Novo Nordisk Investigational Site

Bologna, Italy, 40138

Novo Nordisk Investigational Site

Palermo, Italy, 90127

Novo Nordisk Investigational Site

Pisa, Italy, 56124

Novo Nordisk Investigational Site

Rome, Italy, 00168

Novo Nordisk Investigational Site

Siena, Italy, 53100

Spain

Novo Nordisk Investigational Site

Alcorcón, Spain, 28922

Novo Nordisk Investigational Site

Almeria, Spain, 04009

Novo Nordisk Investigational Site

Hospitalet de Llobregat, Spain, 08907

Novo Nordisk Investigational Site

Pamplona, Spain, 31008

Novo Nordisk Investigational Site

Pozuelo de Alarcon, Spain, 28223

Novo Nordisk Investigational Site

Sevilla, Spain, 41010

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure (1452); Novo Nordisk A/S

  Study Documents (Full-Text)

Documents provided by Novo Nordisk A/S:

Study Protocol  [PDF] June 29, 2018

Statistical Analysis Plan  [PDF] April 12, 2021

More Information

Publications:

Kushner RF, Calanna S, Davies M, Dicker D, Garvey WT, Goldman B, Lingvay I, Thomsen M, Wadden TA, Wharton S, Wilding JPH, Rubino D. Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5. Obesity (Silver Spring). 2020 Jun;28(6):1050-1061. doi: 10.1002/oby.22794.

Wharton S, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jodar E, Kandler K, Rigas G, Wadden TA, Garvey WT. Two-year effect of semaglutide 2.4 mg on control of eating in adults with overweight/obesity: STEP 5. Obesity (Silver Spring). 2023 Mar;31(3):703-715. doi: 10.1002/oby.23673. Epub 2023 Jan 18.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Garvey WT, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jodar E, Kandler K, Rigas G, Wadden TA, Wharton S; STEP 5 Study Group. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med. 2022 Oct;28(10):2083-2091. doi: 10.1038/s41591-022-02026-4. Epub 2022 Oct 10.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT03693430
• Other Study ID Numbers: NN9536-4378; 2017-003726-32 ( Registry Identifier: European Medicines Agency (EudraCT) ); U1111-1202-1740 ( Other Identifier: World Health Organization (WHO) )
• First Posted: October 3, 2018
• Results First Posted: March 23, 2022
• Last Update Posted: July 6, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
• URL: http://novonordisk-trials.com

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Semaglutide; Glucagon-Like Peptide-1 Receptor Agonists; Hypoglycemic Agents; Physiological Effects of Drugs