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A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight

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Novo Nordisk

Status and phase

Active, not recruiting
Phase 3

Conditions

Obesity
Diabetes Mellitus, Type 2

Treatments

Drug: Placebo
Drug: Semaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT05649137
NN9536-7545
2022-002235-60 (EudraCT Number)
U1111-1279-0359 (Other Identifier)

Details and patient eligibility

About

This study will look at how much weight participants will lose and how much blood sugar control they achieve from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. After receiving first dose, the dose of semaglutide will be gradually increased until reaching the target dose. The study will last for about 1.5 years.

Enrollment

513 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female.
  • Age above or equal to 18 years at the time of signing informed consent.
  • BMI greater than or equal to 30.0 kilograms per square meter (kg/m^2).
  • Diagnosed with type 2 diabetes (T2D) greater than or equal to 180 days prior to the day of screening.
  • History of at least one self-reported unsuccessful dietary effort to lose body weight.
  • HbA1c 7.0-10.0 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at screening.

Exclusion criteria

  • A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds [lbs]) within 90 days before screening irrespective of medical records.
  • Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
  • Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square meter (30 mL/min/1.73 m^2) (less than 45 mL/min/1.73 m^2 in participants treated with Sodium-glucose Cotransporter-2 [SGLT2i]) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-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 fundus examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

513 participants in 3 patient groups, including a placebo group

Semaglutide 7.2 mg
Experimental group
Description:
Participants will receive once-weekly injection of semaglutide subcutaneously (s.c.) in 20 week dose escalation period with dose escalation (0.25 milligram \[mg\], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg) every fourth week. Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks until week 72.
Treatment:
Drug: Semaglutide
Drug: Semaglutide
Semaglutide 2.4 mg
Experimental group
Description:
Participants will receive once-weekly s.c. injection of semaglutide in 20 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 72.
Treatment:
Drug: Semaglutide
Drug: Semaglutide
Placebo
Placebo Comparator group
Description:
Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks.
Treatment:
Drug: Placebo

Trial contacts and locations

66

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Data sourced from clinicaltrials.gov

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