Research Study of a New Medicine (NNC9204-1706) in People With Overweight or Obesity

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT03661879

Collaborator

(none)

Enrollment

Location

Arms

12.9

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is testing a new medicine for weight control in people with overweight or obesity. The aim of the study is to find out how safe the study medicine is and how it works in the body. Participants will either get NNC9204-1706 (the new study medicine) or placebo (a dummy medicine) - which treatment participants get is decided by chance. NNC9204-1706 is a new medicine which cannot be prescribed by doctors. Participants will get an injection under the skin of participants' stomach each morning for 10 weeks. A medical tool called NovoPen®4 will be used for the injection. Participants must change the part of the pen including the medicine (the cartridge) each day. The study will last for about 16 weeks. Participants will have at least 17 clinic visits and 10 phone calls with the study doctor. At certain times during the study, participants will have blood drawn and 3 different kinds of heart tests (electrocardiograms). Study doctor will ask participants to answer mental health surveys.

Condition or Disease	Intervention/Treatment	Phase
Metabolism and Nutrition Disorder Obesity	Drug: NNC9204-1706 Drug: Placebo (NNC9204-1706)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Five (5) cohorts are planned. In each cohort, subjects will be randomised in a 3:1 manner to receive either: 1) NNC9204-1706: 9 subjects or 2) Placebo (NNC9204-1706): 3 subjectsFive (5) cohorts are planned. In each cohort, subjects will be randomised in a 3:1 manner to receive either: 1) NNC9204-1706: 9 subjects or 2) Placebo (NNC9204-1706): 3 subjects

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:

A Randomised, Double-blinded, Multiple-dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC9204-1706 in Subjects Being Overweight or With Obesity

Actual Study Start Date :

Sep 12, 2018

Actual Primary Completion Date :

Sep 5, 2019

Actual Study Completion Date :

Oct 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NNC9204-1706 Participants will receive NNC9204-1706 for 10 weeks. There will be a 2-week follow-up period after the treatment period.	Drug: NNC9204-1706 Participants will receive NNC9204-1706 subcutaneous (s.c., under the skin) injection(s) once daily (OD) for 10 weeks. They will either receive the same dose throughout the trial, or the dose will be escalated over a period of 1-3 weeks and continued for at least 7 weeks at the same dose.
Placebo Comparator: Placebo (NNC9204-1706) Participants will receive placebo (NNC9204-1706) for 10 weeks. There will be a 2-week follow-up period after the treatment period.	Drug: Placebo (NNC9204-1706) Participants will receive matching placebo (NNC9204-1706) s.c., injection(s) OD for 10 weeks.

Arm

Intervention/Treatment

Experimental: NNC9204-1706

Participants will receive NNC9204-1706 for 10 weeks. There will be a 2-week follow-up period after the treatment period.

Drug: NNC9204-1706

Participants will receive NNC9204-1706 subcutaneous (s.c., under the skin) injection(s) once daily (OD) for 10 weeks. They will either receive the same dose throughout the trial, or the dose will be escalated over a period of 1-3 weeks and continued for at least 7 weeks at the same dose.

Placebo Comparator: Placebo (NNC9204-1706)

Participants will receive placebo (NNC9204-1706) for 10 weeks. There will be a 2-week follow-up period after the treatment period.

Drug: Placebo (NNC9204-1706)

Participants will receive matching placebo (NNC9204-1706) s.c., injection(s) OD for 10 weeks.

Outcome Measures

Primary Outcome Measures

Number of treatment emergent adverse events (TEAEs) [Days 1-84]
Count of adverse events.

Secondary Outcome Measures

Change in time-profile (msec) in individual corrected QT interval (ΔQTcI) [Day 1, Day 84]
Measured in msec.
AUC0-24h,SS (h*nmol/L); the area under the NNC9204-1706 plasma concentration-time curve from time 0 to 24 hours at steady state [Days 1-84]
Measured in h*nmol/L.
Cmax,SS (nmol/L); the maximum plasma concentration of NNC9204-1706 at steady state [Days 1-84]
Measured in nmol/L.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
Body mass index (BMI) between 25.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

Exclusion Criteria:

Female subject who is of childbearing potential (pre-menopausal and not surgically sterilised) and is sexually active with male partner(s) who are not surgically sterilised (vasectomy) or who is not using highly effective contraceptive methods (Pearl Index less than 1%) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), or are pregnant, breast-feeding or intend to become pregnant.
Male subject who is not surgically sterilised (vasectomy) and is sexually active with female partner(s) and who is not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their nonpregnant female partner(s) (Pearl Index less than 1%), and/or intend to donate sperm in the period from screening until 90 days following administration of the investigational medical product.
Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.

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:

NCT03661879

Other Study ID Numbers:

NN9423-4393
U1111-1208-7677

First Posted:

Sep 7, 2018

Last Update Posted:

Oct 18, 2019

Last Verified:

Oct 1, 2019

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

Nutrition Disorders

Overweight

Study Results

No Results Posted as of Oct 18, 2019