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

Conditions

• Obesity
• Overweight

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• NNC0174-0833 — DRUG
  Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
• Placebo (NNC0174-0833) — DRUG
  Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
• Liraglutide 3.0 mg — DRUG
  Participants will get one dose of liraglutide 3.0 mg once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg daily. The participants will continue on 3.0 mg of liraglutide, once daily up to 26 weeks.
• Placebo (Liraglutide 3.0 mg) — DRUG
  Participants will get one dose of Placebo (liraglutide 3.0 mg) once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg. The participants will continue on Placebo (liraglutide 3.0 mg), once daily up to 26 weeks.

Study Details

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.

Key Dates

Start date

Mar 1, 2019

Status verified

Jul 2024

Primary completion

Mar 2, 2020

Completion

Mar 25, 2021

Study Design

Enrollment

706 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: NNC0174-0833, 4.5 mg
  Patients will receive 4.5 mg of NNC0174-0833 once a week as injections for 26 weeks.
• Experimental: NNC0174-0833, 2.4 mg
  Patients will receive 2.4 mg of NNC0174-0833 once a week as injections for 26 weeks.
• Experimental: NNC0174-0833, 1.2 mg
  Patients will receive 1.2 mg of NNC0174-0833 once a week as injections for 26 weeks.
• Experimental: NNC0174-0833, 0.6 mg
  Patients will receive 0.6 mg of NNC0174-0833 once a week as injections for 26 weeks.
• Experimental: NNC0174-0833 0.3 mg
  Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.
• Placebo Comparator: Placebo 2.4 mg (NNC0174-0833)
  Patients will receive 2.4 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.
• Placebo Comparator: Placebo 4.5 mg (NNC0174-0833)
  Patients will receive 4.5 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.
• Placebo Comparator: Placebo 1.2 mg (NNC0174-0833)
  Patients will receive 1.2 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.
• Placebo Comparator: Placebo 0.6 mg (NNC0174-0833)
  Patients will receive 0.6 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.
• Placebo Comparator: Placebo 0.3 mg (NNC0174-0833)
  Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.
• Active Comparator: Liraglutide 3.0 mg
  Patients will receive 3.0 mg of liraglutide once daily as injections for 26 weeks.
• Placebo Comparator: Placebo 3.0 mg (Liraglutide)
  Patients will receive placebo 3.0 mg(liraglutide) once daily as injections for 26 weeks.

Primary Outcome Measure

Change in Body Weight (%) [ Time Frame: From baseline (week 0) to week 26 ]

Locations (22)

Find similar trials in Anaheim, CA

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