STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: Placebo (semaglutide); Drug: Semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03811574

U1111-1201-1629 (Other Identifier)

NN9536-4382

Details and patient eligibility

About

This study will look at the change in participants' 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 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 participants get is decided by chance. Participants are three 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 skinfold in the stomach, thigh or upper arm. The study will last for about one and a half years. Participants will have 14 clinic visits and 11 phone calls with the study doctor.

Enrollment: 401 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, age more than or equal to 18 years at the time of signing informed consent
• BMI more than or equal to 27.0 kg/m^2 with more than or equal to 2 weight related comorbidities (treated or untreated) or BMI more than or equal to 35.0 kg/m^2 with more than or equal to 1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension or dyslipidaemia (Japan only: or T2D)
• History of at least one self-reported unsuccessful dietary effort to lose body weight
• For subjects with T2D at screening (Japan only): a) Diagnosed with T2D more than or equal to 180 days prior to the day of screening. b) HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)

Exclusion criteria

• A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
• For subjects without T2D at screening: HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
• For subjects with T2D at screening (Japan only): a) 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 co-transporter 2 inhibitor (SGLT2i)) according to chronic kidney disease epidemiology (CKD-EPI) creatinine equation as defined by kidney disease improving global outcome (KDIGO) 2012 by the central laboratory at screening. b) Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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401 participants in 4 patient groups, including a placebo group

Semaglutide 2.4 mg

Experimental group

Description:

Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue semaglutide 2.4 mg until week 68.

Treatment:

Drug: Semaglutide

Placebo (semaglutide 2.4 mg)

Placebo Comparator group

Description:

Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue placebo (semaglutide 2.4 mg) until week 68.

Treatment:

Drug: Placebo (semaglutide)

Semaglutide 1.7 mg

Experimental group

Description:

Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue semaglutide 1.7 mg until week 68.

Treatment:

Drug: Semaglutide

Placebo (semaglutide 1.7 mg)

Placebo Comparator group

Description:

Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue placebo (semaglutide 1.7) until week 68.

Treatment:

Drug: Placebo (semaglutide)