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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT03600480

Collaborator

(none)

Enrollment

Location

Arms

22.6

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight	Drug: NNC0174-0833 Drug: Semaglutide Drug: Placebo (NNC0174-0833)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Sponsor staff involved in the clinical trial is masked according to company standard procedures

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 25, 2018

Actual Primary Completion Date :

Jun 12, 2020

Actual Study Completion Date :

Jun 12, 2020

Arms and Interventions

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.	Drug: NNC0174-0833 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. Drug: Semaglutide 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	Drug: Semaglutide 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. Drug: Placebo (NNC0174-0833) Participants will receive once weekly injections of NNC0174-0833 matched placebo.

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.

Drug: NNC0174-0833

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.

Drug: Semaglutide

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

Drug: Semaglutide

Drug: Placebo (NNC0174-0833)

Participants will receive once weekly injections of NNC0174-0833 matched placebo.

Outcome Measures

Primary Outcome Measures

Number of treatment emergent adverse events (TEAEs) [From first administration of NNC0174-0833 (Day 1) to completion of the post-treatment follow-up (Day 176)]
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 [From last dose (Day 134) until end of treatment (Day 141)]
Measured in nmol*h/L
Cmax,AM833,SS: the maximum concentration of NNC0174-0833 in plasma at steady state [From last dose (Day 134) until end of treatment (Day 141)]
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 [From last dose (Day 134) until end of treatment (Day 141)]
Measured in nmol*h/L
Cmax,sema,SS: the maximum concentration of semaglutide in plasma at steady state [From last dose (Day 134) until end of treatment (Day 141)]
Measured in nmol/L

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Overland Park	Kansas	United States	66212

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Clinical Reporting Anchor and Disclosure 1452, Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT03600480

Other Study ID Numbers:

NN9838-4395
U1111-1203-6796

First Posted:

Jul 26, 2018

Last Update Posted:

Nov 17, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Overweight

Study Results

No Results Posted as of Nov 17, 2021