Clinical trial NCT05040971: Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes
Official title: Efficacy and Safety of Subcutaneous Semaglutide 2.4 mg Once-weekly in Subjects With Obesity and Prediabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-09-10
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study looks at how well a new medicine, called semaglutide, works at helping people with obesity and prediabetes.

This study will look at how much weight participants lose, and if participants can go from having blood sugar that is higher than normal (prediabetes) to having normal blood sugar.

Semaglutide is compared to a "dummy" medicine. The "dummy" medicine looks like semaglutide but has no effect on the body.

In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight.

Participants will either get semaglutide or "dummy" medicine - which treatment they get is decided by chance. Participants are 2 times as likely to get semaglutide as "dummy" medicine.

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 19 months. Participants have to take the study medicine every week for the first 12 months. The last 7 months participants will not take any medication.

Participants will have 14 clinic visits and 1 phone call with the study staff. At 9 of the clinic visits Participants will have blood samples taken. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility criteria: Inclusion Criteria:

* Male or female aged greater than or equal to 18 years at the time of signing informed consent.
* BMI greater than or equal to 30.0 kg/m\^2
* Prediabetes defined as at least one of the following:

  * HbA1c between 6.0 and 6.4 percent (42 and 47 mmol/mol) (both inclusive) as measured by central laboratory at screening.
  * FPG between 5.5 and 6.9 mmol/L (99 and 125 mg/dL) (both inclusive) as measured by central laboratory at screening.

Exclusion Criteria:

* History of type 1 or type 2 diabetes.
* Treatment with glucose-lowering agent(s) within 90 days before screening.
* HbA1c greater than or equal to 6.5 percent (greater than or equal to 48 mmol/mol) as measured by central laboratory at screening.
* FPG greater than or equal to 7.0mmol/L (126 mg/dL) as measured by central laboratory at screening.

A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records.

* Treatment with any medication for the indication of obesity within the past 90 days before screening.

Primary outcomes:
measure: Change in Body Weight (Percentage [%])
timeFrame: From randomisation (week 0) to end of treatment (week 52)
measure: Participants With Change to Normoglycemia
timeFrame: At week 52
Secondary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c)
timeFrame: From randomisation (week 0) to end of treatment (week 52)
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: From randomisation (week 0) to end of treatment (week 52)
measure: Change in Waist Circumference
timeFrame: From randomisation (week 0) to end of treatment (week 52)
measure: Change in Systolic Blood Pressure
timeFrame: From randomisation (week 0) to end of treatment (week 52)
measure: Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline
timeFrame: From randomisation (week 0) to end of treatment (week 52)
measure: Change in Total Cholesterol (mmol/L) - Ratio to Baseline
timeFrame: From randomisation (week 0) to end of treatment (week 52)
measure: Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
timeFrame: From randomisation (week 0) to end of treatment (week 52)
measure: Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
timeFrame: From randomisation (week 0) to end of treatment (week 52)
measure: Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
timeFrame: From randomisation (week 0) to end of treatment (week 52)
measure: Change in Body Weight (Kilogram [Kg])
timeFrame: From randomisation (week 0) to week 52
measure: Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 5% (Yes/No)
timeFrame: At week 52
measure: Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 10% (Yes/No)
timeFrame: At week 52
measure: Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 15% (Yes/No)
timeFrame: At week 52
measure: Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 20% (Yes/No)
timeFrame: At week 52
measure: Change in Pulse
timeFrame: From randomisation (week 0) to end of treatment (week 52)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Calgary
country: Canada
facility: C-endo Diab Endo Clin Calgery
state: Alberta
city: Surrey
country: Canada
facility: Ocean West Research Clinic
state: British Columbia
city: Moncton
country: Canada
facility: G.A. Research Associates Ltd.
state: New Brunswick
city: Brampton
country: Canada
facility: LMC ClinRsrh Inc.Brampton
state: Ontario
city: Concord
country: Canada
facility: LMC Clin Res Inc. Thornhill
state: Ontario
city: Hamilton
country: Canada
facility: Wharton Med Clin Trials
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Med Res Group
state: Ontario
city: London
country: Canada
facility: Milestone Research
state: Ontario
city: Toronto
country: Canada
facility: Toronto Sleep Institute/MedSleep
state: Ontario
city: Toronto
country: Canada
facility: Diabetes Heart Research Centre
state: Ontario
city: Montreal
country: Canada
facility: Centre Medical Acadie
state: Quebec
city: Saint-Laurent
country: Canada
facility: LMC Clin Rsrch Inc. (Montreal)
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre de recherché du CHUS
state: Quebec
city: Terrebonne
country: Canada
facility: Ctr de Med Metab de Lanaudiere
state: Quebec
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital Diabetes og Hormonsygdomme
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital Endokrinologisk forsknings afsnit 159
city: Helsinki
country: Finland
facility: Obesity Research Unit
city: Jyväskylä
country: Finland
facility: StudyCor
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Sevilla
country: Spain
facility: Hospital Infanta Luisa
city: Rotherham
country: United Kingdom
facility: Clifton Medical Centre
state: South Yorkshire
city: Bradford-on-Avon
country: United Kingdom
facility: The Health Centre
city: Coventry
country: United Kingdom
facility: WISDEM Centre
city: Exmouth
country: United Kingdom
facility: Claremont Medical Practice
city: Harrow
country: United Kingdom
facility: GP Direct
city: London
country: United Kingdom
facility: Guys Hospital
city: Soham
country: United Kingdom
facility: The Staploe Medical Centre
city: Strensall
country: United Kingdom
facility: MyHealth
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References: