NCT03552757|CompletedPhase 3ResultsFDA Drug

Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity

STEP 2

Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity and Type 2 Diabetes

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN9536-4374U1111-1200-81482017-003414-10

Study Type

interventional

Target

1,210

Locations

13 countries

Sites

147

Timeline

RegisteredJun 2018

StartedJun 2018

CompletionMay 2020

Brief Summary

This study will look at the change in the 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. In addition to taking the study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight. Overweight and obesity is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to have a beneficial impact on the blood sugar levels. The participant will either get semaglutide or "dummy" medicine - which treatment the participant get is decided by chance. The participant will need to take 2 injections at the same time 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 1.5 years

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

1,210

participants targeted

Target at P75+ for phase_3 obesity

Timeline

Completed

Started Jun 2018

Geographic Reach

13 countries

147 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

First Submitted

Initial submission to the registry

May 30, 2018

Completed

5 days until next milestone

Study Start

First participant enrolled

June 4, 2018

Completed

8 days until next milestone

First Posted

Study publicly available on registry

June 12, 2018

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2020

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

August 11, 2021

Completed

Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

1.8 years

First QC Date

May 30, 2018

Results QC Date

June 16, 2021

Last Update Submit

November 8, 2021

Conditions

Obesity Overweight

Outcome Measures

Primary Outcomes (2)

Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo
Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from both in-trial and on-treatment observation 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: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2-week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Baseline (week 0) to week 68
Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo
Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
At week 68

Secondary Outcomes (39)

Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg
Baseline (week 0) to week 68
Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg
At week 68
Change in Waist Circumference
Baseline (week 0) to week 68
Change in Body Weight (Kg)
Baseline (week 0) to week 68
Change in BMI
Baseline (week 0) to week 68
+34 more secondary outcomes

Study Arms (3)

Semaglutide 1.0 mg

EXPERIMENTAL

Participants will receive semaglutide 1.0 mg and semaglutide placebo I during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.

Drug: Semaglutide 1.0 mgDrug: Placebo I (Semaglutide)

Semaglutide 2.4 mg

EXPERIMENTAL

Participants will receive semaglutide 2.4 mg and semaglutide placebo II during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.

Drug: Semaglutide 2.4 mgDrug: Placebo II (Semaglutide)

Semaglutide placebo I/II

PLACEBO COMPARATOR

Participants will receive semaglutide placebo I and II during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.

Drug: Placebo I (Semaglutide)Drug: Placebo II (Semaglutide)

Interventions

Semaglutide 1.0 mgDRUG

Subcutaneous (s.c.) injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.

Semaglutide 1.0 mg

Semaglutide 2.4 mgDRUG

Subcutaneous injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.

Semaglutide 2.4 mg

Placebo I (Semaglutide)DRUG

S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 2.4 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.

Semaglutide 1.0 mgSemaglutide placebo I/II

Placebo II (Semaglutide)DRUG

S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 1.0 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.

Semaglutide 2.4 mgSemaglutide placebo I/II

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female, age greater than or equal to 18 years at the time of signing informed consent
Body Mass Index (BMI) greater than or equal to 27 kg/m\^2 '
History of at least one self-reported unsuccessful dietary effort to lose body weight
Diagnosed with type 2 diabetes (haemoglobin A1c 7-10% (53-86 mmol/mol) (both inclusive)) 180 days or longer prior to the day of screening

You may not qualify if:

A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 mL/min/1.73 m\^2 (less than 60 ml/min/1.73 m\^2 in subjects treated with Sodium-glucose Cotransporter 2 Inhibitors) according to chronic kidney disease (CKD)-Epidemiology Collaboration (EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (e.g. optometrist) within the past 90 days prior to screening or in the period between screening and randomisation

Contact the study team to confirm eligibility.