Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes (STEP 10)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: Drug: Semaglutide 2.4 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05040971

NN9536-4734

2020-002939-29 (EudraCT Number)

U1111-1253-1956 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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207 participants in 2 patient groups, including a placebo group

Semaglutide

Experimental group

Description:

Participants will receive subcutaneus (s.c.) semaglutide 2.4 mg once weekly for 52 weeks

Treatment:

Drug: Semaglutide 2.4 mg

Placebo (semaglutide)

Placebo Comparator group

Description:

Participants will receive subcutaneus (s.c.) placebo (semaglutide) once weekly for 52 weeks

Treatment:

Drug: Placebo