Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program (STEP 3)

• ClinicalTrials.gov Identifier: NCT03611582
• Recruitment Status: Completed
• First Posted: August 2, 2018
• Results First Posted: July 9, 2021
• Last Update Posted: July 9, 2021
• 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 participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. Together with the medicine, the participant will also be part of an intensive lifestyle program where the participant will have talks with study staff about healthy food choices, what the participant can do to lose weight and be more physically active. The participant will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. The participant 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. For the first 2 months the participant will be on a low calorie diet. The diet is made up of bars, shakes and 1 low calorie pre-prepared meal for each day. The study will last for about 1.5 years. The participant will have 32 clinic visits 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: 611 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect and Safety of Semaglutide 2.4 mg Once-weekly as Adjunct to Intensive Behavioural Therapy in Subjects With Overweight or Obesity
• Actual Study Start Date: August 1, 2018
• Actual Primary Completion Date: March 18, 2020
• Actual Study Completion Date: April 28, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Semaglutide; Participants will receive semaglutide 2.4 mg during 68-week treatment period in addition to intensive behavioural therapy.	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: Semaglutide placebo; Participants will receive semaglutide placebo during 68-week treatment period in addition to intensive behavioural therapy.	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. Change in Body Weight (%) [ Time Frame: Baseline (week 0) to week 68 ]
   Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
2. Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% [ Time Frame: After 68 weeks ]
   Number of participants who achieved greater than or equal to (≥) 5% weight loss after 68 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 endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption.

Secondary Outcome Measures :

1. Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10% [ Time Frame: After 68 weeks ]
   Number of participants who achieved greater than or equal to (≥) 10% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 10% weight loss whereas 'No' infers number of participants who have not achieved ≥ 10% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
2. Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15% [ Time Frame: After 68 weeks ]
   Number of participants who achieved greater than or equal to (≥) 15% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 15% weight loss whereas 'No' infers number of participants who have not achieved ≥ 15% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
3. Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20% [ Time Frame: After 68 weeks ]
   Number of participants who achieved greater than or equal to (≥) 20% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 20% weight loss whereas 'No' infers number of participants who have not achieved ≥ 20% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
4. Change in Waist Circumference [ Time Frame: Baseline (week 0) to week 68 ]
   Change in waist circumference from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
5. Change in Systolic Blood Pressure [ Time Frame: Baseline (week 0) to week 68 ]
   Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
6. Change in Short Form-36 (SF-36) - Physical Functioning Score [ Time Frame: Baseline (week 0) to week 68 ]
   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™ questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). The 0-100 scale scores 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. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
7. Change in Body Weight (Kg) [ Time Frame: Baseline (week 0) to week 68 ]
   Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
8. Change in Body Mass Index [ Time Frame: Baseline (week 0) to week 68 ]
   Change in body mass index from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
9. Change in HbA1c (%) [ Time Frame: Baseline (week 0) to week 68 ]
   Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
10. Change in HbA1c (mmol/Mol) [ Time Frame: Baseline (week 0) to week 68 ]
    Change in HbA1c from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
11. Change in Fasting Plasma Glucose [ Time Frame: Baseline (week 0) to week 68 ]
    Change in fasting plasma glucose from week 0 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
12. Change in Fasting Serum Insulin [ Time Frame: Baseline (week 0) to week 68 ]
    Change in fasting serum insulin from week 0 to week 68 [measured as milli-international units per milliliter (mIU/mL)] is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
13. Change in Diastolic Blood Pressure [ Time Frame: Baseline (week 0) to week 68 ]
    Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
14. Change in Total Cholesterol [ Time Frame: Baseline (week 0) to week 68 ]
    Change in fasting total cholesterol from baseline (week 0) to week 68 (measured as mg/dL) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
15. Change in High-density Lipoproteins (HDL) [ Time Frame: Baseline (week 0) to week 68 ]
    Change in fasting HDL from baseline (week 0) to week 68 (measured as mg/dL) is presented as ratio to baseline.The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
16. Change in Low-density Lipoproteins (LDL) [ Time Frame: Baseline (week 0) to week 68 ]
    Change in fasting LDL from baseline (week 0) to week 68 (measured as mg/dL) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
17. Change in Very Low Density Lipoprotein (VLDL) [ Time Frame: Baseline (week 0) to week 68 ]
    Change in fasting VLDL from baseline (week 0) to week 68 (measured as mg/dL) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
18. Change in Free Fatty Acids [ Time Frame: Baseline (week 0) to week 68 ]
    Change in fasting free fatty acids from baseline (week 0) to week 68 (measured as mg/dL) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
19. Change in Triglycerides [ Time Frame: Baseline (week 0) to week 68 ]
    Change in fasting triglycerides from baseline (week 0) to week 68 (measured as mg/dL) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
20. Change in High Sensitivity C-reactive Protein [ Time Frame: Baseline (week 0) to week 68 ]
    Change in high sensitivity C-reactive protein from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
21. Change in Plasminogen Activator Inhibitor-1 Activity [ Time Frame: Baseline (week 0) to week 68 ]
    Change in plasminogen activator inhibitor-1 activity from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
22. Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score [ Time Frame: After 68 weeks ]
    The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, "Yes" infers number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period which is uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).
23. Change in Body Weight [ Time Frame: Baseline (week 0) to week 8 ]
    Change in body weight from baseline (week 0) to week 8 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
24. Number of Treatment-emergent Adverse Events (AEs) [ Time Frame: Baseline (week 0) to week 75 ]
    An adverse event (AE) was defined as any unfavorable 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 treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to treatment. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).
25. Number of Serious Adverse Events (SAEs) [ Time Frame: Baseline (week 0) to week 75 ]
    A serious adverse event (SAE) is 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 75 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).
26. Change in Pulse [ Time Frame: Baseline (week 0) to week 68 ]
    Change in pulse from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
27. Change in Amylase [ Time Frame: Baseline (week 0) to week 68 ]
    Change in amylase (measured as U/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
28. Change in Lipase [ Time Frame: Baseline (week 0) to week 68 ]
    Change in lipase (measured as U/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
29. Change in Calcitonin [ Time Frame: Baseline (week 0) to week 68 ]
    Change in calcitonin (measured as ng/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (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 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:

• Hemoglobin A1c 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, 35294

Novo Nordisk Investigational Site

Montgomery, Alabama, United States, 36106

United States, Arizona

Novo Nordisk Investigational Site

Peoria, Arizona, United States, 85381

United States, California

Novo Nordisk Investigational Site

Anaheim, California, United States, 92801

Novo Nordisk Investigational Site

Escondido, California, United States, 92025

Novo Nordisk Investigational Site

Fresno, California, United States, 93720

Novo Nordisk Investigational Site

Fullerton, California, United States, 92835

Novo Nordisk Investigational Site

Huntington Beach, California, United States, 92648

Novo Nordisk Investigational Site

Los Angeles, California, United States, 90057

Novo Nordisk Investigational Site

Walnut Creek, California, United States, 94598

United States, Colorado

Novo Nordisk Investigational Site

Golden, Colorado, United States, 80401

United States, Florida

Novo Nordisk Investigational Site

Kissimmee, Florida, United States, 34744

Novo Nordisk Investigational Site

Panama City, Florida, United States, 32401

Novo Nordisk Investigational Site

Plantation, Florida, United States, 33324

United States, Georgia

Novo Nordisk Investigational Site

Roswell, Georgia, United States, 30076

United States, Hawaii

Novo Nordisk Investigational Site

Honolulu, Hawaii, United States, 96814

United States, Illinois

Novo Nordisk Investigational Site

Chicago, Illinois, United States, 60607

Novo Nordisk Investigational Site

Evanston, Illinois, United States, 60201-2477

Novo Nordisk Investigational Site

Skokie, Illinois, United States, 60077

United States, New York

Novo Nordisk Investigational Site

Albany, New York, United States, 12203

Novo Nordisk Investigational Site

Endwell, New York, United States, 13760

United States, North Carolina

Novo Nordisk Investigational Site

Chapel Hill, North Carolina, United States, 27517

Novo Nordisk Investigational Site

Greensboro, North Carolina, United States, 27408

Novo Nordisk Investigational Site

Hickory, North Carolina, United States, 28601

Novo Nordisk Investigational Site

Raleigh, North Carolina, United States, 27609

Novo Nordisk Investigational Site

Wilmington, North Carolina, United States, 28401

United States, Pennsylvania

Novo Nordisk Investigational Site

Philadelphia, Pennsylvania, United States, 19104-3317

United States, South Carolina

Novo Nordisk Investigational Site

Charleston, South Carolina, United States, 29425

Novo Nordisk Investigational Site

Mount Pleasant, South Carolina, United States, 29464

United States, Tennessee

Novo Nordisk Investigational Site

Knoxville, Tennessee, United States, 37912

United States, Texas

Novo Nordisk Investigational Site

Austin, Texas, United States, 78731

Novo Nordisk Investigational Site

Dallas, Texas, United States, 75226

Novo Nordisk Investigational Site

Dallas, Texas, United States, 75230

Novo Nordisk Investigational Site

Dallas, Texas, United States, 75231

Novo Nordisk Investigational Site

Rockwall, Texas, United States, 75032

Novo Nordisk Investigational Site

Round Rock, Texas, United States, 78681

United States, Utah

Novo Nordisk Investigational Site

Saint George, Utah, United States, 84790

United States, Virginia

Novo Nordisk Investigational Site

Arlington, Virginia, United States, 22206

Novo Nordisk Investigational Site

Newport News, Virginia, United States, 23606

Novo Nordisk Investigational Site

Winchester, Virginia, United States, 22601-3834

United States, Washington

Novo Nordisk Investigational Site

Olympia, Washington, United States, 98502

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] August 3, 2020

Statistical Analysis Plan  [PDF] July 28, 2020

More Information

Publications of Results:

Wadden TA, Bailey TS, Billings LK, Davies M, Frias JP, Koroleva A, Lingvay I, O'Neil PM, Rubino DM, Skovgaard D, Wallenstein SOR, Garvey WT; STEP 3 Investigators. Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1403-1413. doi: 10.1001/jama.2021.1831.

Other 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.

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

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-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT03611582
• Other Study ID Numbers: NN9536-4375; U1111-1200-8199 ( Other Identifier: World Health Organization (WHO) )
• First Posted: August 2, 2018
• Results First Posted: July 9, 2021
• Last Update Posted: July 9, 2021
• Last Verified: June 2021

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