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

Phase 1

Completed

• Conditions: Metabolism and Nutrition Disorder; Obesity
• Interventions: Drug: NNC9204-1706; Drug: Placebo (NNC9204-1706)

• Registration Number: NCT03661879
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-07
• Study Start: 2018-09-12
• Primary Completion: 2019-09-05
• Status Verified: 2019-10
• Study Completion: 2019-10-09
• Last Update Submitted: 2019-10-17
• Last Update Posted: 2019-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events (TEAEs)	Days 1-84	Count of adverse events.

Secondary Outcome Measures

Name	Time	Method
Cmax,SS (nmol/L); the maximum plasma concentration of NNC9204-1706 at steady state	Days 1-84	Measured in nmol/L.
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.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Overland Park, Kansas, United States