A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Novo Nordisk A/S
Study ID
NCT03600480
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • NNC0174-0833 — DRUG
    Participants will receive increasing dose levels of 0.16 mg, 0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg of NNC0174-0833 (subcutaneous \[s.c.\], in a lifted fold of the abdominal skin) injection once weekly starting with a very low dose and then escalated every 4 weeks to a slightly higher dose each time. Each participant will only be given one dose level.
  • Semaglutide — DRUG
    Participants will receive 2.4 mg of semaglutide (s.c., in a lifted fold of the abdominal skin) injection once weekly starting with a very low dose and then escalated every 4 weeks to a slightly higher dose each time.
  • Placebo (NNC0174-0833) — DRUG
    Participants will receive once weekly injections of NNC0174-0833 matched placebo.

Study Details

The aim of this study is to find out how NNC0174-0833 taken with semaglutide works in people who are overweight or obese. Both study medicines have been investigated on their own. The study also looks at how the study medicines behave in participant's body and how they are removed from the participant's body. Participants will get 1 of the following 2 treatments - which treatment any participant gets is decided by chance: Semaglutide (a new medicine) and NNC0174-0833 (a potential new medicine), or semaglutide and placebo (a "dummy medicine similar to the study medicine but without active ingredients). Participants will get 2 injections per week for 20 weeks. A study nurse at the clinic will inject the medicine with a needle in a skin fold in the participant's stomach area. The study will last for about 16 months, but duration of participation for any participant will last up to about 7.5 months. Participants will have 28 clinic visits with the study staff and some will be overnight visits. Participants will be asked about their health, medical history and habits including mental health questionnaires.

Key Dates

Start date
Jul 25, 2018
Status verified
Nov 2021
Primary completion
Jun 12, 2020
Completion
Jun 12, 2020

Study Design

Enrollment
96 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NNC0174-0833+Semaglutide
    Participants will receive increasing doses of NNC0174-0833 along with semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks.
  • Active Comparator: Placebo (NNC0174-0833)+Semaglutide
    Participants will receive placebo (NNC0174-0833) along with semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks

Primary Outcome Measure

Number of treatment emergent adverse events (TEAEs) [ Time Frame: From first administration of NNC0174-0833 (Day 1) to completion of the post-treatment follow-up (Day 176) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteOverland ParkKansas66212-

Find similar trials in Overland Park, KS

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Novo Nordisk Investigational Site· Overland Park, KS

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