Back to results

Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or Obesity

Primary Purpose

Metabolism and Nutrition Disorder, Obesity

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

NNC9204-1177 A 1.0 mg/mL

PLACEBO

About this trial

This is an interventional treatment trial for Metabolism and Nutrition Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NNC9204-1177

Placebo

Arm Description

Dose trial with a sequential trial design

Outcomes

Primary Outcome Measures

Number of treatment emergent adverse events (TEAEs)

Count of events

Secondary Outcome Measures

The area under the NNC9204-1177 serum concentration-time curve at steady state

Calculated based on NNC9204-1177 measured in blood.

The maximum serum concentration of NNC9204-1177 at steady state

Calculated based on NNC9204-1177 measured in blood.

The time to maximum serum concentration of NNC9204-1177

Calculated based on NNC9204-1177 measured in blood.

The terminal half-life of NNC9204-1177 from steady state

Calculated based on NNC9204-1177 measured in blood.

Full Information

NCT ID

NCT03308721

First Posted

October 9, 2017

Last Updated

December 22, 2021

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT03308721

Brief Title

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

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

October 16, 2017 (Actual)

Primary Completion Date

January 3, 2020 (Actual)

Study Completion Date

January 3, 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

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolism and Nutrition Disorder, Obesity

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

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NNC9204-1177

Arm Type

Experimental

Arm Description

Dose trial with a sequential trial design

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

NNC9204-1177 A 1.0 mg/mL

Intervention Description

Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks. Dose gradually increased to 6000 μg.

Intervention Type

Drug

Intervention Name(s)

PLACEBO

Intervention Description

Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.

Primary Outcome Measure Information:

Title

Number of treatment emergent adverse events (TEAEs)

Description

Count of events

Time Frame

Day 1-110

Secondary Outcome Measure Information:

Title

The area under the NNC9204-1177 serum concentration-time curve at steady state

Description

Calculated based on NNC9204-1177 measured in blood.

Time Frame

0-168 hours

Title

The maximum serum concentration of NNC9204-1177 at steady state

Description

Calculated based on NNC9204-1177 measured in blood.

Time Frame

Day 78-110

Title

The time to maximum serum concentration of NNC9204-1177

Description

Calculated based on NNC9204-1177 measured in blood.

Time Frame

Day 78-110

Title

The terminal half-life of NNC9204-1177 from steady state

Description

Calculated based on NNC9204-1177 measured in blood.

Time Frame

Day 78-110

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

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 novonordisk-trials.com

Learn more about this trial

Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or Obesity

We'll reach out to this number within 24 hrs