- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03600480
A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese
November 16, 2021 updated by: Novo Nordisk A/S
Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Combination With Semaglutide in Subjects Being Overweight or With Obesity
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Overland Park, Kansas, United States, 66212
- Novo Nordisk INvestigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
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.
|
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
|
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.
Participants will receive once weekly injections of NNC0174-0833 matched placebo.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Count of events
|
From first administration of NNC0174-0833 (Day 1) to completion of the post-treatment follow-up (Day 176)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Measured in nmol*h/L
|
From last dose (Day 134) until end of treatment (Day 141)
|
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)
|
Measured in nmol/L
|
From last dose (Day 134) until end of treatment (Day 141)
|
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)
|
Measured in nmol*h/L
|
From last dose (Day 134) until end of treatment (Day 141)
|
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)
|
Measured in nmol/L
|
From last dose (Day 134) until end of treatment (Day 141)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 25, 2018
Primary Completion (Actual)
June 12, 2020
Study Completion (Actual)
June 12, 2020
Study Registration Dates
First Submitted
July 17, 2018
First Submitted That Met QC Criteria
July 17, 2018
First Posted (Actual)
July 26, 2018
Study Record Updates
Last Update Posted (Actual)
November 17, 2021
Last Update Submitted That Met QC Criteria
November 16, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9838-4395
- U1111-1203-6796 (Other Identifier: World Health Organization (WHO))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
According to the Novo Nordisk disclosure commitment on novonordisktrials.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Istituto Auxologico ItalianoRecruiting
Clinical Trials on NNC0174-0833
-
Novo Nordisk A/SCompletedObesity | OverweightUnited States
-
Novo Nordisk A/SCompletedObesity | OverweightUnited States
-
Novo Nordisk A/SCompletedOverweight and ObesityChina
-
Novo Nordisk A/SCompletedObesity | Metabolism and Nutrition DisorderUnited States
-
Novo Nordisk A/SCompletedObesity | Metabolism and Nutrition DisorderUnited States
-
Novo Nordisk A/SRecruiting
-
Novo Nordisk A/SCompletedObesity | OverweightUnited States, United Kingdom, Canada, Denmark, Finland, Serbia, Poland, Japan, South Africa, Ireland
-
Novo Nordisk A/SActive, not recruitingNon-alcoholic SteatohepatitisSpain, Denmark, Taiwan, Korea, Republic of, Australia, Canada, India, Singapore, United States, Turkey, Poland, Italy, Belgium, Puerto Rico, United Kingdom, Malaysia, Germany, Portugal, Bulgaria, Czechia, France, Greece, Japan, Russian...
-
Novo Nordisk A/SCompleted
-
Josep Rodes-CabauiVascularCompletedCoronary Heart DiseaseSpain