Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT03600480Other idNN9838-4395Other idU1111-1203-6796

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 96 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 25 Jul 2018
Primary completion: 12 Jun 2020
Completion: 12 Jun 2020
First posted: 26 Jul 2018
Last update posted: 17 Nov 2021
Conditions: Obesity · Overweight

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2018201920202021

Ph 1
A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese
NCT03600480
25 Jul 2018 to 12 Jun 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

NNC0174-0833Drug
SemaglutideDrug
Placebo (NNC0174-0833)Drug

Arms2

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 outcomes1

Outcomes the sponsor listed as primary.

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)
Registry description
Count of events

Secondary outcomes(4)

AUC0-168h,AM833,SS: the area under the NNC0174-0833 plasma concentration-time curve from 0 to 168 hours at steady state
Time frame · From last dose (Day 134) until end of treatment (Day 141)
Registry description
Measured in nmol\*h/L
Cmax,AM833,SS: the maximum concentration of NNC0174-0833 in plasma at steady state
Time frame · From last dose (Day 134) until end of treatment (Day 141)
Registry description
Measured in nmol/L
AUC0-168h,sema,SS: the area under the semaglutide plasma concentration-time curve from 0 to 168 hours at steady state
Time frame · From last dose (Day 134) until end of treatment (Day 141)
Registry description
Measured in nmol\*h/L
Cmax,sema,SS: the maximum concentration of semaglutide in plasma at steady state
Time frame · From last dose (Day 134) until end of treatment (Day 141)
Registry description
Measured in nmol/L

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

29 results

Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2·4 mg for weight management: a randomised, controlled, phase 1b trial.

Enebo et al. 2021Lancet (London, England)cited by 241

PMID 33894838DOI 10.1016/s0140-6736(21)00845-xPUB-33894838

Full text at the publisher29 results

Publisher page See results (29)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 55 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Male or female of non-childbearing potential, aged 18-55 years (both inclusive) at the time of signing informed consent. * Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. Exclusion Criteria: * Any disorder at screening which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol. * Male subject who is not sexually abstinent or surgically sterilised (vasectomy) and is sexually active with female partner(s) of childbearing potential and is not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the last dose of investigational medical product.

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