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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 5, 2018

Estimated Primary Completion Date

January 29, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in body weight[ Time Frame: Week 0, week 104 ]

Measured in %

Subjects who achieve (yes/no): body weight reduction more than or equal to 5%[ Time Frame: Week 0, week 104 ]

Number of subjects

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Subjects who achieve (yes/no): body weight reduction more than or equal to 10%[ Time Frame: Week 0, week 104 ]
Number of subjects
Subjects who achieve (yes/no): body weight reduction more than or equal to 15%[ Time Frame: Week 0, week 104 ]
Number of subjects
Change in waist circumference[ Time Frame: Week 0, week 104 ]
Measured in cm
Change in systolic blood pressure[ Time Frame: Week 0, week 104 ]
Measured in mmHg
Change in body weight[ Time Frame: Week 0, week 104 ]
Measured in kg
Change in body mass index (BMI)[ Time Frame: Week 0, week 104 ]
Measured in kg/m^2
Change in hemoglobin A1c (HbA1c)[ Time Frame: Week 0, week 104 ]
Measured in %
Change in HbA1c[ Time Frame: Week 0, week 104 ]
Measured in mmol/mol
Change in fasting plasma glucose[ Time Frame: Week 0, week 104 ]
Measured in mg/dL
Change in fasting serum insulin[ Time Frame: Week 0, week 104 ]
Measured in micro IU/mL
Change in diastolic blood pressure[ Time Frame: Week 0, week 104 ]
Measured in mmHg
Change in total cholesterol[ Time Frame: Week 0, week 104 ]
Measured in mg/dL
Change in high density lipoprotein (HDL) cholesterol[ Time Frame: Week 0, week 104 ]
Measured in mg/dL
Change in low density lipoprotein (LDL) cholesterol[ Time Frame: Week 0, week 104 ]
Measured in mg/dL
Change in very low density lipoprotein (VLDL) cholesterol[ Time Frame: Week 0, week 104 ]
Measured in mg/dL
Change in free fatty acids[ Time Frame: Week 0, week 104 ]
Measured in mg/dL
Change in triglycerides[ Time Frame: Week 0, week 104 ]
Measured in mg/dL
Change in high sensitivity C-Reactive Protein[ Time Frame: Week 0, week 104 ]
Measured in mg/L
Change in body weight[ Time Frame: Week 0, week 52 ]
Measured in %
Change in body weight[ Time Frame: Week 0, week 52 ]
Measured in kg
Change in BMI[ Time Frame: Week 0, week 52 ]
Measured in kg/m^2
Change in waist circumference[ Time Frame: Week 0, week 52 ]
Measured in cm
Subjects who achieve (yes/no): body weight reduction more than or equal to 5%[ Time Frame: Week 0, week 52 ]
Number of subjects
Subjects who achieve (yes/no): body weight reduction more than or equal to 10%[ Time Frame: Week 0, week 52 ]
Number of subjects
Subjects who achieve (yes/no): body weight reduction more than or equal to 15%[ Time Frame: Week 0, week 52 ]
Number of subjects
Number of treatment-emergent adverse events (TEAEs)[ Time Frame: Week 0, week 111 ]
Number of events
Number of serious adverse events (SAEs)[ Time Frame: Week 0, week 111 ]
Number of events
Change in pulse[ Time Frame: Week 0, week 104 ]
Measured in beats per minute
Change in amylase[ Time Frame: Week 0, week 104 ]
Measured in U/L
Change in lipase[ Time Frame: Week 0, week 104 ]
Measured in U/L
Change in calcitonin[ Time Frame: Week 0, week 104 ]
Measured in ng/L

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Two-year Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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
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

Study Arms

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.
Placebo Comparator: Placebo
Participants will receive placebo (semaglutide) during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

March 19, 2021

Estimated Primary Completion Date

January 29, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Hungary|Italy|Spain|United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

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

IPD Sharing Statement

Plan to Share IPD:

Yes

Responsible Party

，

Study Sponsor ^ICMJE

Novo Nordisk A/S

Collaborators ^ICMJE

Investigators ^ICMJE

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

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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