History of Changes for Study: NCT03574597

Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (SELECT)

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Study Record Versions

Version	Submitted Date	Changes
1	June 21, 2018	None (earliest Version on record)
2	September 6, 2018	Study Status, Contacts/Locations and Eligibility
3	October 25, 2018	Recruitment Status, Contacts/Locations, Study Status and Oversight
4	October 30, 2018	Contacts/Locations and Study Status
5	November 1, 2018	Contacts/Locations and Study Status
6	November 5, 2018	Contacts/Locations and Study Status
7	November 7, 2018	Contacts/Locations and Study Status
8	November 13, 2018	Contacts/Locations and Study Status
9	November 15, 2018	Contacts/Locations and Study Status
10	November 20, 2018	Contacts/Locations and Study Status
11	November 22, 2018	Contacts/Locations and Study Status
12	November 27, 2018	Contacts/Locations and Study Status
13	November 29, 2018	Contacts/Locations and Study Status
14	December 2, 2018	Contacts/Locations and Study Status
15	December 5, 2018	Contacts/Locations and Study Status
16	December 7, 2018	Contacts/Locations and Study Status
17	December 12, 2018	Contacts/Locations and Study Status
18	December 14, 2018	Contacts/Locations and Study Status
19	December 17, 2018	Contacts/Locations and Study Status
20	December 19, 2018	Contacts/Locations and Study Status
21	December 27, 2018	Contacts/Locations and Study Status
22	January 1, 2019	Contacts/Locations and Study Status
23	January 3, 2019	Contacts/Locations and Study Status
24	January 8, 2019	Contacts/Locations and Study Status
25	January 10, 2019	Contacts/Locations and Study Status
26	January 15, 2019	Contacts/Locations and Study Status
27	January 17, 2019	Contacts/Locations and Study Status
28	January 22, 2019	Contacts/Locations and Study Status
29	January 24, 2019	Contacts/Locations and Study Status
30	January 29, 2019	Contacts/Locations and Study Status
31	February 1, 2019	Contacts/Locations and Study Status
32	February 3, 2019	Contacts/Locations and Study Status
33	February 6, 2019	Contacts/Locations and Study Status
34	February 8, 2019	Contacts/Locations and Study Status
35	February 14, 2019	Contacts/Locations and Study Status
36	February 27, 2019	Contacts/Locations and Study Status
37	March 1, 2019	Contacts/Locations and Study Status
38	March 4, 2019	Contacts/Locations and Study Status
39	March 8, 2019	Contacts/Locations and Study Status
40	March 13, 2019	Contacts/Locations and Study Status
41	March 18, 2019	Contacts/Locations and Study Status
42	March 22, 2019	Contacts/Locations and Study Status
43	March 28, 2019	Contacts/Locations and Study Status
44	April 1, 2019	Contacts/Locations and Study Status
45	April 4, 2019	Contacts/Locations and Study Status
46	April 11, 2019	Contacts/Locations and Study Status
47	May 9, 2019	Contacts/Locations and Study Status
48	May 14, 2019	Contacts/Locations, Eligibility and Study Status
49	May 23, 2019	Contacts/Locations and Study Status
50	May 29, 2019	Contacts/Locations and Study Status
51	June 7, 2019	Contacts/Locations and Study Status
52	June 19, 2019	Contacts/Locations and Study Status
53	June 21, 2019	Contacts/Locations and Study Status
54	June 28, 2019	Contacts/Locations and Study Status
55	July 5, 2019	Contacts/Locations and Study Status
56	July 11, 2019	Contacts/Locations and Study Status
57	July 17, 2019	Contacts/Locations and Study Status
58	July 23, 2019	Contacts/Locations and Study Status
59	July 30, 2019	Contacts/Locations and Study Status
60	August 1, 2019	Study Status and Contacts/Locations
61	August 5, 2019	Contacts/Locations and Study Status
62	August 8, 2019	Contacts/Locations and Study Status
63	August 12, 2019	Contacts/Locations and Study Status
64	August 14, 2019	Contacts/Locations and Study Status
65	August 20, 2019	Contacts/Locations and Study Status
66	August 28, 2019	Contacts/Locations and Study Status
67	September 2, 2019	Contacts/Locations and Study Status
68	September 9, 2019	Contacts/Locations and Study Status
69	September 11, 2019	Contacts/Locations and Study Status
70	September 16, 2019	Contacts/Locations and Study Status
71	September 18, 2019	Contacts/Locations and Study Status
72	September 23, 2019	Contacts/Locations and Study Status
73	September 26, 2019	Contacts/Locations and Study Status
74	September 30, 2019	Contacts/Locations and Study Status
75	October 7, 2019	Contacts/Locations and Study Status
76	October 9, 2019	Contacts/Locations and Study Status
77	October 14, 2019	Contacts/Locations and Study Status
78	October 16, 2019	Contacts/Locations and Study Status
79	October 21, 2019	Contacts/Locations and Study Status
80	October 24, 2019	Contacts/Locations and Study Status
81	October 28, 2019	Contacts/Locations and Study Status
82	October 30, 2019	Contacts/Locations and Study Status
83	November 1, 2019	Study Status and Contacts/Locations
84	November 6, 2019	Contacts/Locations and Study Status
85	November 8, 2019	Contacts/Locations and Study Status
86	November 8, 2019	Outcome Measures and Study Status
87	November 14, 2019	Contacts/Locations and Study Status
88	November 18, 2019	Contacts/Locations and Study Status
89	November 21, 2019	Contacts/Locations and Study Status
90	November 27, 2019	Contacts/Locations and Study Status
91	November 29, 2019	Contacts/Locations and Study Status
92	December 3, 2019	Contacts/Locations and Study Status
93	December 5, 2019	Contacts/Locations and Study Status
94	December 9, 2019	Contacts/Locations and Study Status
95	January 6, 2020	Contacts/Locations and Study Status
96	January 7, 2020	Contacts/Locations and Study Status
97	January 8, 2020	Contacts/Locations and Study Status
98	January 13, 2020	Contacts/Locations and Study Status
99	January 16, 2020	Contacts/Locations and Study Status
100	January 22, 2020	Contacts/Locations and Study Status
101	January 29, 2020	Contacts/Locations and Study Status
102	January 30, 2020	Contacts/Locations and Study Status
103	February 5, 2020	Contacts/Locations and Study Status
104	February 6, 2020	Contacts/Locations and Study Status
105	February 10, 2020	Contacts/Locations and Study Status
106	February 12, 2020	Contacts/Locations and Study Status
107	February 13, 2020	Contacts/Locations and Study Status
108	February 17, 2020	Contacts/Locations and Study Status
109	February 24, 2020	Contacts/Locations and Study Status
110	February 26, 2020	Contacts/Locations and Study Status
111	February 27, 2020	Contacts/Locations and Study Status
112	March 9, 2020	Contacts/Locations and Study Status
113	March 30, 2020	Contacts/Locations and Study Status
114	April 1, 2020	Study Status and Contacts/Locations
115	May 4, 2020	Contacts/Locations and Study Status
116	May 6, 2020	Contacts/Locations and Study Status
117	May 11, 2020	Contacts/Locations and Study Status
118	May 19, 2020	Contacts/Locations and Study Status
119	May 27, 2020	Contacts/Locations and Study Status
120	June 2, 2020	Study Status and Contacts/Locations
121	June 8, 2020	Contacts/Locations and Study Status
122	June 11, 2020	Contacts/Locations and Study Status
123	June 15, 2020	Contacts/Locations and Study Status
124	June 22, 2020	Contacts/Locations and Study Status
125	June 25, 2020	Contacts/Locations and Study Status
126	July 2, 2020	Study Status and Contacts/Locations
127	July 20, 2020	Contacts/Locations and Study Status
128	August 5, 2020	Study Status and Contacts/Locations
129	August 13, 2020	Contacts/Locations and Study Status
130	August 17, 2020	Contacts/Locations and Study Status
131	August 25, 2020	Contacts/Locations and Study Status
132	September 10, 2020	Contacts/Locations and Study Status
133	September 21, 2020	Contacts/Locations and Study Status
134	September 23, 2020	Contacts/Locations and Study Status
135	September 29, 2020	Contacts/Locations and Study Status
136	October 6, 2020	Contacts/Locations and Study Status
137	October 15, 2020	Contacts/Locations and Study Status
138	October 26, 2020	Contacts/Locations and Study Status
139	October 29, 2020	Contacts/Locations and Study Status
140	November 4, 2020	Study Status and Contacts/Locations
141	November 9, 2020	Contacts/Locations and Study Status
142	November 12, 2020	Contacts/Locations and Study Status
143	November 17, 2020	Contacts/Locations and Study Status
144	November 25, 2020	Contacts/Locations and Study Status
145	December 16, 2020	Contacts/Locations and Study Status
146	January 13, 2021	Contacts/Locations and Study Status
147	January 22, 2021	Contacts/Locations and Study Status
148	February 2, 2021	Study Status and Contacts/Locations
149	February 9, 2021	Contacts/Locations and Study Status
150	February 11, 2021	Contacts/Locations and Study Status
151	February 18, 2021	Contacts/Locations and Study Status
152	February 22, 2021	Contacts/Locations and Study Status
153	March 2, 2021	Study Status and Contacts/Locations
154	March 4, 2021	Contacts/Locations and Study Status
155	March 5, 2021	Contacts/Locations and Study Status
156	March 8, 2021	Contacts/Locations and Study Status
157	March 9, 2021	Contacts/Locations and Study Status
158	March 18, 2021	Contacts/Locations and Study Status
159	March 23, 2021	Contacts/Locations and Study Status
160	March 24, 2021	Contacts/Locations and Study Status
161	March 26, 2021	Contacts/Locations and Study Status
162	April 6, 2021	Contacts/Locations and Study Status
163	April 7, 2021	Contacts/Locations and Study Status
164	April 14, 2021	Contacts/Locations and Study Status
165	April 21, 2021	Contacts/Locations and Study Status
166	May 18, 2021	Contacts/Locations and Study Status
167	May 26, 2021	Contacts/Locations and Study Status
168	June 14, 2021	Contacts/Locations and Study Status
169	June 18, 2021	Contacts/Locations and Study Status
170	June 22, 2021	Contacts/Locations and Study Status
171	June 24, 2021	Contacts/Locations and Study Status
172	June 25, 2021	Contacts/Locations and Study Status
173	June 28, 2021	Contacts/Locations and Study Status
174	July 1, 2021	Study Status and Contacts/Locations
175	July 7, 2021	Contacts/Locations and Study Status
176	July 28, 2021	Contacts/Locations, References and Study Status
177	September 3, 2021	Contacts/Locations and Study Status
178	September 14, 2021	Contacts/Locations and Study Status
179	November 15, 2021	Contacts/Locations and Study Status
180	November 29, 2021	Recruitment Status, Contacts/Locations and Study Status
181	March 18, 2022	Contacts/Locations and Study Status
182	December 11, 2022	Contacts/Locations and Study Status
183	December 19, 2022	Contacts/Locations and Study Status
184	February 8, 2023	Contacts/Locations, Study Status and References
185	February 28, 2023	Contacts/Locations and Study Status
186	May 30, 2023	Recruitment Status, Contacts/Locations and Study Status
187	June 2, 2023	Recruitment Status, Contacts/Locations, Study Status and Study Design
188	June 7, 2023	Study Design and Study Status
189	June 18, 2023	Contacts/Locations and Study Status
190	June 27, 2023	Recruitment Status, Contacts/Locations, Study Status and Study Design
191	July 1, 2023	Contacts/Locations and Study Status
192	August 10, 2023	Study Status and Contacts/Locations
193	October 6, 2023	Contacts/Locations, Study Status and Eligibility
194	October 18, 2023	Contacts/Locations and Study Status
195	December 22, 2023	Contacts/Locations, Study Status and References
196	January 22, 2024	Contacts/Locations and Study Status
197	February 13, 2024	Contacts/Locations and Study Status
198	March 31, 2024	Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	EX9536-4388
Brief Title:	Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (SELECT)
Official Title:	SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity
Secondary IDs:	2017-003380-35 [Registry Identifier: European Medicines Agency (EudraCT)] U1111-1200-5564 [World Health Organization (WHO)]

Study Status


Record Verification:	June 2018
Overall Status:	Not yet recruiting
Study Start:	October 24, 2018
Primary Completion:	September 28, 2023 [Anticipated]
Study Completion:	September 28, 2023 [Anticipated]

First Submitted:	June 21, 2018
First Submitted that Met QC Criteria:	June 21, 2018
First Posted:	July 2, 2018 [Actual]

Last Update Submitted that Met QC Criteria:	June 21, 2018
Last Update Posted:	July 2, 2018 [Actual]

Sponsor/Collaborators


Sponsor:	Novo Nordisk A/S
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

Brief Summary:

The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. The participant will either get semaglutide (active medicine) or placebo ("dummy" medicine). Which treatment the participants get is decided by chance. The participant's chance of getting semaglutide or placebo is the same. The participant will get the study medicine in a pen. The participants will need to use the pen to inject the study medicine in a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have up to 25 clinic visits with the study doctor.

Detailed Description:

Conditions


Conditions:	Overweight Obesity
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	17500 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Semaglutide Participants will receive semaglutide as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months.	Drug: Semaglutide Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Subjects will start semaglutide treatment at 0.24 mg; dose will gradually be increased every 4 weeks up to 2.4 mg.
Placebo Comparator: Placebo (semaglutide) Participants will receive placebo (semaglutide) as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months.	Drug: Placebo (semaglutide) Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Participants will receive placebo at an equivalent dose to semaglutide.

Outcome Measures


Primary Outcome Measures:
1.	Time to first occurrence of a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, or non-fatal stroke [ Time Frame: 0-59 months ] Measured in months
Secondary Outcome Measures:
1.	Time to CV death [ Time Frame: 0-59 months ] Measured in months
2.	Time to all-cause death [ Time Frame: 0-59 months ] Measured in months
3.	Time to first occurrence of an expanded composite CV endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation or unstable angina requiring hospitalisation [ Time Frame: 0-59 months ] Measured in months
4.	Time to first occurrence of a composite heart failure endpoint consisting of: heart failure hospitalisation, urgent heartfailure visit or CV death [ Time Frame: 0-59 months ] Measured in months
5.	Time to first occurrence of a composite endpoint consisting of: all-cause death, non-fatal myocardial infarction, or non-fatal stroke [ Time Frame: 0-59 months ] Measured in months
6.	Time to first occurrence of non-fatal myocardial infarction [ Time Frame: 0-59 months ] Measured in months
7.	Time to first occurrence of non-fatal stroke [ Time Frame: 0-59 months ] Measured in months
8.	Time to first occurrence of coronary revascularisation [ Time Frame: 0-59 months ] Measured in months
9.	Time to first occurrence of unstable angina requiring hospitalisation [ Time Frame: 0-59 months ] Measured in months
10.	Time to first occurrence of heart failure hospitalisation or urgent heart failure visit [ Time Frame: 0-59 months ] Measured in months
11.	Time to first occurrence of HbA1c greater than or equal to 48 mmol/mol (6.5%) [ Time Frame: 0-59 months ] Measured in months
12.	Time to first occurrence of a 5-component composite nephropathy endpoint [ Time Frame: 0-59 months ] Measured in months. A 5-component composite nephropathy endpoint consists of: onset of persistent macroalbuminuria, persistent 50% reduction in estimated Glomerular Filtration Rate (eGFR) compared with baseline (randomisation), onset of persistent eGFR less than 15 ml/min/1.73m^2, initiation of chronic renal replacement therapy (dialysis or transplantation) or renal death.
13.	Time to HbA1c greater than or equal to 39 mmol/mol (5.7%) for subjects with a screening HbA1c less than 39 mmol/mol (5.7%) [ Time Frame: 0-59 months ] Measured in months
14.	Subjects with HbA1c less than 39 mmol/mol (5.7%) at each visit where HbA1c is assessed for subjects with a screening HbA1c greater than or equal to 39 mmol/mol (5.7%) [ Time Frame: 0-59 months ] Proportion of subjects
15.	Change in systolic blood pressure [ Time Frame: Week 0, year 2 ] Measured in mm Hg
16.	Change in diastolic blood pressure [ Time Frame: Week 0, year 2 ] Measured in mm Hg
17.	Change in pulse [ Time Frame: Week 0, year 2 ] Measured in beats per minute
18.	Change in High sensitivity C-Reactive Protein (hsCRP) [ Time Frame: Week 0, year 2 ] Measured in mg/dL
19.	Change in total cholesterol [ Time Frame: Week 0, year 2 ] Measured in mg/dL
20.	Change in high density lipoprotein (HDL) cholesterol [ Time Frame: Week 0, year 2 ] Measured in mg/dL
21.	Change in low density lipoprotein (LDL) cholesterol [ Time Frame: Week 0, year 2 ] Measured in mg/dL
22.	Change in triglycerides [ Time Frame: Week 0, year 2 ] Measured in mg/dL
23.	Change in body weight [ Time Frame: Week 0, year 2 ] Measured in %
24.	Change in waist circumference [ Time Frame: Week 0, year 2 ] Measured in cm
25.	Change in EuroQol five dimensions five level (EQ-5D-5L) questionnaire [ Time Frame: Week 0, year 2 ] The EQ-5D-5L questionnaire will be used to estimate the impact on subjects' health-related quality of life and provides a description of subjects' problems by dimensions (descriptive system), a score for overall self-rated health (visual analogue scale [VAS]) as well as an index score (EQ-5D-5L index). EQ-5D index score range: 0 to 1 and EQ-5D-VAS: range 0 to 100. A higher score indicates better self reported health status.
26.	Change in total score weight related sign and symptom measure [ Time Frame: Week 0, year 2 ] The weight related sign and symptom measure assesses the presence and bother associated with weight-related symptoms using a self-rated VAS. It is a tool to assess the multifaceted aspects of obesity on symptom experience in subjects with overweight or obesity.
27.	Change in haemoglobin A1c (HbA1c) [ Time Frame: Screening (up to 3 weeks before randomisation at week 0), week 104 ] Measured in %
28.	Change in HbA1c [ Time Frame: Screening (up to 3 weeks before randomisation at week 0), week 104 ] Measured in mmol/mol

Eligibility


Minimum Age:	45 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Male or female, age greater than or equal to 45 years at the time of signing informed consent Body mass index (BMI) greater than or equal to 27 kg/m^2 Have established cardiovascular (CV) disease as evidenced by at least one of the following: prior myocardial infarction; prior stroke (ischemic or haemorrhagic stroke); or symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) less than 0.85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease Exclusion Criteria: Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening HbA1c greater than or equal to 48 mmol/mol (6.5 %) as measured by the central laboratory at screening History of type 1 or type 2 diabetes (history of gestational diabetes is allowed)

Contacts/Locations


Central Contact Person:	Novo Nordisk Telephone: (+1) 866-867-7178 Email: clinicaltrials@novonordisk.com
Study Officials:	Clinical Reporting Anchor and Disclosure (1452) Study Director Novo Nordisk A/S
Locations:

IPDSharing


Plan to Share IPD:	Yes According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
	Supporting Information:
	Time Frame:
	Access Criteria:
	URL: http://novonordisk-trials.com

References


Links:
Available IPD/Information: