OverweightPhase 1NCT04010786
A Research Study Investigating NNC0247-0829 for Weight Management in People With Overweight or Obesity
A Phase 1 study testing NNC0247-0829 in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- NNC0247-0829
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2019to 21 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
ICON Early Phase Services, LLC
San Antonio, Texas, 78209
About this study
Official title: 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.
- Conditions
- Overweight, Obesity
- Being tested
- NNC0247-0829, Placebo (NNC0247-0829)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0247-0829Drug
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 (NNC0247-0829)Drug
Participants will receive either single or multiple doses of placebo given s.c. in a lifted fold of the stomach skin.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment NNC0247-0829 | Experimental | 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 Receives: Drug: NNC0247-0829 |
| Placebo | Placebo comparator | In each of the 6 single dose cohorts, 2 subjects will receive placebo. In the 2 multiple dose cohorts, 4 subjects will receive placebo Receives: Drug: Placebo (NNC0247-0829) |
What is being measured
The primary outcome is the main question the study is designed to answer.
For single dose (SD) cohorts: Number of treatment emergent adverse events (TEAEs)
Number of events
Measured: From time of first dosing (Day 1) until Day 71
For multiple dose (MD) cohorts: Number of treatment emergent adverse events (TEAEs)
Number of events
Measured: From time of first dosing (Day 1) until Day 85
Secondary outcomes (5)
For SD cohorts: Number of injection site reactions
Number of events
Measured: From time of first dosing (Day 1) until Day 71
For SD cohorts: Occurrence of anti-NNC0247-0829 antibodies
Number of events
Measured: From time of first dosing (Day 1) until Day 71
For MD cohorts: Number of injection site reactions
Number of events
Measured: From time of first dosing (Day 1) until Day 85
For MD cohorts: Occurrence of anti-NNC0247-0829 antibodies
Number of events
Measured: 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
nmol/L*h
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start11 Jul 2019
- Primary completion11 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- First human dose trial; a single-centre, placebo-controlled, double-blind (within cohorts), randomised SD and MD ascending dose trial with a sequential trial design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010786
- Sponsor's protocol ID
- NN9215-4424
- Other IDs
- U1111-1226-5167
- Status last verified
- Jan 2024
- First submitted
- 3 Jul 2019
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Injections of NNC0247-0829 in Adults With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT04010786
- Acronym / sponsor ID
- NN9215-4424
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 11 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- First human dose trial; a single-centre, placebo-controlled, double-blind (within cohorts), randomised SD and MD ascending dose trial with a sequential trial design
| Arm | Type | Receives |
|---|---|---|
| Active treatment NNC0247-0829 | Experimental | Drug: NNC0247-0829Up 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 |
| Placebo | Placebo comparator | Drug: Placebo (NNC0247-0829)In each of the 6 single dose cohorts, 2 subjects will receive placebo. In the 2 multiple dose cohorts, 4 subjects will receive placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC0247-0829Participants 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. | Drug | Active treatment NNC0247-0829 |
| Placebo (NNC0247-0829)Participants will receive either single or multiple doses of placebo given s.c. in a lifted fold of the stomach skin. | Drug | Placebo |
Primary outcome
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
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
5 secondary outcomes
For SD cohorts: Number of injection site reactions
Time frame: 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
For MD cohorts: Number of injection site reactions
Time frame: 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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC0247-0829 in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For single dose (SD) cohorts: Number of treatment emergent adverse events (TEAEs) (time frame: From time of first dosing (Day 1) until Day 71). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.