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

NCT03600480 · Completed

Last updated 2026-05-28

This study is testing how the experimental drug NNC0174-0833, combined with semaglutide, affects people who are overweight or obese.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 96 people

Who can join Ages 18–55 · all sexes

Timeline Started 2018-07 · est. completion 2020-06

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT03600480 ↗

Description as written by the study sponsor.

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.

Treatments tested

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.

Main thing measured	Number of treatment emergent adverse events (TEAEs)
Sponsor	Novo Nordisk A/S
Conditions studied	Obesity, Overweight
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03600480 ↗