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Cagrilintide

AM-833, Long-acting amylin analogue

Quick Stats
Studies 57
Trials 38
Overview Studies Clinical Trials
Completed PHASE1 INTERVENTIONAL NCT03600480

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

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.

Interventions

Name: NNC0174-0833
Type: DRUG
Description: 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.
Name: Semaglutide
Type: DRUG
Description: 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.
Name: Placebo (NNC0174-0833)
Type: DRUG
Description: Participants will receive once weekly injections of NNC0174-0833 matched placebo.

Primary Outcomes

Measure: Number of treatment emergent adverse events (TEAEs)
TimeFrame: From first administration of NNC0174-0833 (Day 1) to completion of the post-treatment follow-up (Day 176)
Description: Count of events

Trial Information

NCT ID

NCT03600480

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Novo Nordisk A/S

Last Updated

December 15, 2025