A Research Study Investigating NNC0247-0829 for Weight Management in People With Overweight or Obesity

January 22, 2024 updated by: Novo Nordisk A/S

Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Injections of NNC0247-0829 in Adults With Overweight or Obesity

This study looks at NNC0247-0829 (a potential new medicine) for weight management in people with overweight or obesity. The study looks at how NNC0247-0829 works in the body. Participants will either get NNC0247-0829 or placebo (a 'dummy' medicine) - which treatment is decided by chance. NNC0247-0829 is an experimental medicine which has not been approved by the US FDA. Participants will get either 1 injection or a total of 4 injections (one week apart) by a study nurse at the clinic depending on what group they are in. The study will last for about 18 months, but participation will last from 11 to 23 weeks. This will depend on the group participants are in. Participants will attend 8 to 14 visits at the clinic with the study staff. Some participants will have one 16-day, 15-night visit and one 2-day, 1-night visit. Others will have two 2-day, 1-night visits. At all visits except one, participants will have blood tests and other checks. They will be asked about their health, medical history and habits including mental health questionnaires.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78209
        • ICON Early Phase Services, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female not of childbearing potential (CBP) or male, aged 18-60 years (both inclusive) at the time of signing informed consent.
  • Body mass index (BMI) between 27.0 and 34.9 kg/m^2 (both inclusive) in the SD cohorts and between 27.0 and 39.9 kg/m^2 (both inclusive) in the MD cohorts at screening. Overweight or obesity should be due to excess adipose tissue, as judged by the investigator.

Exclusion Criteria:

  • Male subject who is not surgically sterilised (vasectomised) and is sexually active with female partner of childbearing potential in the absence of highly effective contraception.
  • Any disorder, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
  • Use of prescription or non-prescription products, including herbal products and non-routine vitamins, within 14 days prior to screening. Mild painkillers are permitted until 24h prior to screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active treatment NNC0247-0829
Up to 6 single dose cohorts are planned with 10 subjects in each; 8 will receive active treatment. Up to 2 multiple dose cohorts are planned with 12 subjects in each; 8 will receive active treatment
Drug: NNC0247-0829
Participants will receive either single or multiple doses given subcutaneously (s.c., under the skin) in a lifted fold of the stomach skin. Dose level and number of doses will depend on the cohort.
Placebo Comparator: Placebo
In each of the 6 single dose cohorts, 2 subjects will receive placebo. In the 2 multiple dose cohorts, 4 subjects will receive placebo
Drug: Placebo (NNC0247-0829)
Participants will receive either single or multiple doses of placebo given s.c. in a lifted fold of the stomach skin.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
For single dose (SD) cohorts: Number of treatment emergent adverse events (TEAEs)
Time Frame: From time of first dosing (Day 1) until Day 71
Number of events
From time of first dosing (Day 1) until Day 71
For multiple dose (MD) cohorts: Number of treatment emergent adverse events (TEAEs)
Time Frame: From time of first dosing (Day 1) until Day 85
Number of events
From time of first dosing (Day 1) until Day 85

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
For SD cohorts: Number of injection site reactions
Time Frame: From time of first dosing (Day 1) until Day 71
Number of events
From time of first dosing (Day 1) until Day 71
For SD cohorts: Occurrence of anti-NNC0247-0829 antibodies
Time Frame: From time of first dosing (Day 1) until Day 71
Number of events
From time of first dosing (Day 1) until Day 71
For MD cohorts: Number of injection site reactions
Time Frame: From time of first dosing (Day 1) until Day 85
Number of events
From time of first dosing (Day 1) until Day 85
For MD cohorts: Occurrence of anti-NNC0247-0829 antibodies
Time Frame: From time of first dosing (Day 1) until Day 85
Number of events
From time of first dosing (Day 1) until Day 85
For (SD) cohorts: The area under the NNC0247-0829 serum concentration-time curve from time 0 to infinity
Time Frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (from Day 71 up to Day 134, depending on the dose cohort)
nmol/L*h
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (from Day 71 up to Day 134, depending on the dose cohort)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 11, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9215-4424
  • U1111-1226-5167 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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