Clinical trial NCT03308721: Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or Obesity
Official title: A Multiple Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Multiple Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2017-10-12
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study looks at a new study medicine for weight management in people with overweight or obesity. The aim of this study is to find out how safe and tolerable the study medicine is. The study also looks at how the study medicine behaves in the body and how it is removed from the body.

Participants will either get NNC9204-1177 (the new study medicine) or placebo (a formula that looks like the study medicine but does not have active ingredients). Which treatment participants get will be decided by chance.

NNC9204-1177 has not been approved by the United States Food and Drug Administration. Its use in this study is experimental. Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.

The study will last for about 5 months. Participants will have 19 clinic visits with the study doctor. At certain times during the study, participants will have blood draws and 3 different kinds of electrocardiograms. Participants will answer mental health questionnaires. Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 27.0 and 39.9 kg/m2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator

Exclusion Criteria:

* Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
* Subjects, aged at least 40 years, with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk greater than or equal to 5%
* Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) who are 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), or who intend to donate sperm in the period from screening until 3 months following last administration of the investigational medical product
* Female subjects who are of child bearing potential (pre-menopausal and not surgically sterilised) and are sexually active with male partner(s) who are not surgically sterilised (vasectomy) and who are not using highly effective contraceptive methods (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), or who are pregnant, breast-feeding or intend to become pregnant

Primary outcomes:
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: Day 1-110
Secondary outcomes:
measure: The area under the NNC9204-1177 serum concentration-time curve at steady state
timeFrame: 0-168 hours
measure: The maximum serum concentration of NNC9204-1177 at steady state
timeFrame: Day 78-110
measure: The time to maximum serum concentration of NNC9204-1177
timeFrame: Day 78-110
measure: The terminal half-life of NNC9204-1177 from steady state
timeFrame: Day 78-110
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
Study officials:
References: