Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: Placebo (NNC0174-0833); Drug: NNC0174-0833; Drug: Liraglutide 3.0 mg; Drug: Placebo (Liraglutide 3.0 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03856047

NN9838-4433

2018-001945-14 (Registry Identifier)

U1111-1214-0429 (Other Identifier)

Details and patient eligibility

About

This study will look at the change in body weight in people taking NNC0174-0833, liraglutide and "dummy" medicine, from the start to the end of the study. As well as 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 take NNC0174-0833, liraglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take one injection once a week or once a day, depending on the treatment. 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 8 months. Participants will have 12 clinic visits with the study doctor.

Enrollment: 706 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older at the time of signing the informed consent.
• Female subject of non-childbearing potential or Male subject who is surgically sterilised (vasectomy) or who is willing to use adequate contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial').
• BMI equal to 30.0 kg/m^2 or greater or BMI equal to 27.0 kg/m^2 or greater with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension or dyslipidaemia (to be assessed at the investigator's discretion).

Exclusion criteria

• HbA1c equal to 48 mmol/mol (6.5 percentage) or greater as measured by the central laboratory at screening.
• A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior to screening irrespective of medical records.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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706 participants in 12 patient groups, including a placebo group

NNC0174-0833, 4.5 mg

Experimental group

Description:

Patients will receive 4.5 mg of NNC0174-0833 once a week as injections for 26 weeks.

Treatment:

Drug: NNC0174-0833

NNC0174-0833, 2.4 mg

Experimental group

Description:

Patients will receive 2.4 mg of NNC0174-0833 once a week as injections for 26 weeks.

Treatment:

Drug: NNC0174-0833

NNC0174-0833, 1.2 mg

Experimental group

Description:

Patients will receive 1.2 mg of NNC0174-0833 once a week as injections for 26 weeks.

Treatment:

Drug: NNC0174-0833

NNC0174-0833, 0.6 mg

Experimental group

Description:

Patients will receive 0.6 mg of NNC0174-0833 once a week as injections for 26 weeks.

Treatment:

Drug: NNC0174-0833

NNC0174-0833 0.3 mg

Experimental group

Description:

Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.

Treatment:

Drug: NNC0174-0833

Placebo 2.4 mg (NNC0174-0833)

Placebo Comparator group

Description:

Patients will receive 2.4 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.

Treatment:

Drug: Placebo (NNC0174-0833)

Placebo 4.5 mg (NNC0174-0833)

Placebo Comparator group

Description:

Patients will receive 4.5 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.

Treatment:

Drug: Placebo (NNC0174-0833)

Placebo 1.2 mg (NNC0174-0833)

Placebo Comparator group

Description:

Patients will receive 1.2 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.

Treatment:

Drug: Placebo (NNC0174-0833)

Placebo 0.6 mg (NNC0174-0833)

Placebo Comparator group

Description:

Patients will receive 0.6 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.

Treatment:

Drug: Placebo (NNC0174-0833)

Placebo 0.3 mg (NNC0174-0833)

Placebo Comparator group

Description:

Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.

Treatment:

Drug: Placebo (NNC0174-0833)

Liraglutide 3.0 mg

Active Comparator group

Description:

Patients will receive 3.0 mg of liraglutide once daily as injections for 26 weeks.

Treatment:

Drug: Liraglutide 3.0 mg

Placebo 3.0 mg (Liraglutide)

Placebo Comparator group

Description:

Patients will receive placebo 3.0 mg(liraglutide) once daily as injections for 26 weeks.

Treatment:

Drug: Placebo (Liraglutide 3.0 mg)