Back to resultsA Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese
Primary Purpose
Obesity, Overweight
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NNC0174-0833
Semaglutide
Placebo (NNC0174-0833)
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
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.
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NNC0174-0833+Semaglutide
Placebo (NNC0174-0833)+Semaglutide
Arm Description
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 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
Outcomes
Primary Outcome Measures
Number of treatment emergent adverse events (TEAEs)
Count of events
Secondary Outcome Measures
AUC0-168h,AM833,SS: the area under the NNC0174-0833 plasma concentration-time curve from 0 to 168 hours at steady state
Measured in nmol*h/L
Cmax,AM833,SS: the maximum concentration of NNC0174-0833 in plasma at steady state
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
Measured in nmol*h/L
Cmax,sema,SS: the maximum concentration of semaglutide in plasma at steady state
Measured in nmol/L
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03600480
Brief Title
A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese
Official Title
Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Combination With Semaglutide in Subjects Being Overweight or With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
June 12, 2020 (Actual)
Study Completion Date
June 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NNC0174-0833+Semaglutide
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo (NNC0174-0833)+Semaglutide
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
NNC0174-0833
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Placebo (NNC0174-0833)
Intervention Description
Participants will receive once weekly injections of NNC0174-0833 matched placebo.
Primary Outcome Measure Information:
Title
Number of treatment emergent adverse events (TEAEs)
Description
Count of events
Time Frame
From first administration of NNC0174-0833 (Day 1) to completion of the post-treatment follow-up (Day 176)
Secondary Outcome Measure Information:
Title
AUC0-168h,AM833,SS: the area under the NNC0174-0833 plasma concentration-time curve from 0 to 168 hours at steady state
Description
Measured in nmol*h/L
Time Frame
From last dose (Day 134) until end of treatment (Day 141)
Title
Cmax,AM833,SS: the maximum concentration of NNC0174-0833 in plasma at steady state
Description
Measured in nmol/L
Time Frame
From last dose (Day 134) until end of treatment (Day 141)
Title
AUC0-168h,sema,SS: the area under the semaglutide plasma concentration-time curve from 0 to 168 hours at steady state
Description
Measured in nmol*h/L
Time Frame
From last dose (Day 134) until end of treatment (Day 141)
Title
Cmax,sema,SS: the maximum concentration of semaglutide in plasma at steady state
Description
Measured in nmol/L
Time Frame
From last dose (Day 134) until end of treatment (Day 141)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Reporting Anchor and Disclosure 1452
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisktrials.com
IPD Sharing URL
http://novonordisk-trials.com
Citations:
PubMed Identifier
33894838
Citation
Enebo LB, Berthelsen KK, Kankam M, Lund MT, Rubino DM, Satylganova A, Lau DCW. 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. Lancet. 2021 May 8;397(10286):1736-1748. doi: 10.1016/S0140-6736(21)00845-X. Epub 2021 Apr 22.
Results Reference
result
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A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese
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