ObesityPhase 1NCT03787225
A Research Study of How NNC0174-0833 Behaves in Japanese and Caucasian Volunteers Who Are Normal Weight, Overweight or With Obesity
A Phase 1 study testing NNC0174-0833 in people with Obesity and Overweight, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
The aim of this study is to look at how the study medicine behaves in the participant's body and how it is removed from the participant's body. The study compares Japanese and Caucasian people who are normal weight, overweight or with obesity. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- NNC0174-0833
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2019to 4 Jun 2019
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male, aged 18-55 years (both inclusive) at the time of signing informed consent.
- For Japanese subjects, both parents of Japanese descent and both paternal and maternal grandparents of Japanese descent.
- For Caucasian subjects, self-reported European descent or white Latin-American descent.
- Body mass index (BMI) between 20.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Body weight between 60 and 110 kg (both inclusive) at screening
Who cannot join
- Male subject who is not surgically sterilised (vasectomy) and is sexually active (with female partner[s] of childbearing potential), 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 non-pregnant female partner(s) (Pearl Index less than 1%), or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product.
- Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
Glendale, California, 91206
About this study
Official title: Investigation of Pharmacokinetic Properties, Safety and Tolerability of Single Subcutaneous Doses of NNC0174-0833 in Male Japanese and Caucasian Subjects Being Normal Weight, Overweight or With Obesity
The aim of this study is to look at how the study medicine behaves in the participant's body and how it is removed from the participant's body. The study compares Japanese and Caucasian people who are normal weight, overweight or with obesity. The participants will either get NNC0174-0833 (a potential new medicine) or placebo (a "dummy" medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get 1 injection by a study nurse at the clinic. The injection will be with a needle in a skin fold in the participant's stomach area. The study will last for about 4 months, but duration of participation for any participant will last up to about 2 months. The participants will have 8 clinic visits with the study staff.
- Conditions
- Obesity, Overweight
- Being tested
- NNC0174-0833, Placebo (NNC0174-0833)
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0174-0833Drug
Participants will receive dose levels of 0.3, 0.9 or 1.8 mg of NNC0174-0833 subcutaneously. Each participant will receive only one dose.
Placebo (NNC0174-0833)Drug
Participants will receive NNC0174-0833 matched placebo subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| NNC0174-0833 (0.3 mg) | Experimental | Participants will receive single dose of NNC0174-0833 Receives: Drug: NNC0174-0833 |
| NNC0174-0833 (0.9 mg) | Experimental | Participants will receive single dose of NNC0174-0833 Receives: Drug: NNC0174-0833 |
| NNC0174-0833 (1.8 mg) | Experimental | Participants will receive single dose of NNC0174-0833 Receives: Drug: NNC0174-0833 |
| Placebo (NNC0174-0833) | Placebo comparator | Participants will receive placebo (NNC0174-0833) Receives: Drug: Placebo (NNC0174-0833) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞,AM833: the area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after single dose
Measured in h*nmol/L
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary outcomes (2)
Cmax,AM833: the maximum concentration of NNC0174-0833 in plasma
Measured in nmol/L
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Number of treatment emergent adverse events (TEAEs)
Count of events
Measured: From time of first dosing (Day 1) until completion of the post-treatment follow-up visit (Day 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start7 Jan 2019
- Primary completion4 Jun 2019
- Study completion4 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Participants will be randomised to 1 of 6 treatment arms, in 3 receiving active NNC0174-0833 and 3 receiving placebo. For statistical analysis and reporting of results, data from the 3 placebo arms will be pooled.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 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
- NCT03787225
- Sponsor's protocol ID
- NN9838-4483
- Other IDs
- U1111-1219-7303
- Status last verified
- Jun 2019
- First submitted
- 21 Dec 2018
- Last updated
- 24 Jun 2019
- 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 novonordisktrials.com
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacokinetic Properties, Safety and Tolerability of Single Subcutaneous Doses of NNC0174-0833 in Male Japanese and Caucasian Subjects Being Normal Weight, Overweight or With Obesity
- ClinicalTrials.gov ID
- NCT03787225
- Acronym / sponsor ID
- NN9838-4483
- Conditions
- Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 26 Dec 2018 (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.
The aim of this study is to look at how the study medicine behaves in the participant's body and how it is removed from the participant's body. The study compares Japanese and Caucasian people who are normal weight, overweight or with obesity. The participants will either get NNC0174-0833 (a potential new medicine) or placebo (a "dummy" medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get 1 injection by a study nurse at the clinic. The injection will be with a needle in a skin fold in the participant's stomach area. The study will last for about 4 months, but duration of participation for any participant will last up to about 2 months. The participants will have 8 clinic visits with the study staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomised to 1 of 6 treatment arms, in 3 receiving active NNC0174-0833 and 3 receiving placebo. For statistical analysis and reporting of results, data from the 3 placebo arms will be pooled.
| Arm | Type | Receives |
|---|---|---|
| NNC0174-0833 (0.3 mg) | Experimental | Drug: NNC0174-0833Participants will receive single dose of NNC0174-0833 |
| NNC0174-0833 (0.9 mg) | Experimental | Drug: NNC0174-0833Participants will receive single dose of NNC0174-0833 |
| NNC0174-0833 (1.8 mg) | Experimental | Drug: NNC0174-0833Participants will receive single dose of NNC0174-0833 |
| Placebo (NNC0174-0833) | Placebo comparator | Drug: Placebo (NNC0174-0833)Participants will receive placebo (NNC0174-0833) |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male, aged 18-55 years (both inclusive) at the time of signing informed consent.
- For Japanese subjects, both parents of Japanese descent and both paternal and maternal grandparents of Japanese descent.
- For Caucasian subjects, self-reported European descent or white Latin-American descent.
- Body mass index (BMI) between 20.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Body weight between 60 and 110 kg (both inclusive) at screening
Key exclusion criteria (2 listed)
- Male subject who is not surgically sterilised (vasectomy) and is sexually active (with female partner[s] of childbearing potential), 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 non-pregnant female partner(s) (Pearl Index less than 1%), or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product.
- Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
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 |
|---|---|---|
| NNC0174-0833Participants will receive dose levels of 0.3, 0.9 or 1.8 mg of NNC0174-0833 subcutaneously. Each participant will receive only one dose. | Drug | NNC0174-0833 (0.3 mg), NNC0174-0833 (0.9 mg), NNC0174-0833 (1.8 mg) |
| Placebo (NNC0174-0833)Participants will receive NNC0174-0833 matched placebo subcutaneously. | Drug | Placebo (NNC0174-0833) |
Primary outcome
AUC0-∞,AM833: the area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after single dose
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Measured in h*nmol/L
2 secondary outcomes
Cmax,AM833: the maximum concentration of NNC0174-0833 in plasma
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Number of treatment emergent adverse events (TEAEs)
Time frame: From time of first dosing (Day 1) until completion of the post-treatment follow-up visit (Day 36)
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 24 Jun 2019.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisktrials.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 NNC0174-0833 in people with Obesity and Overweight, 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 5 inclusion and 2 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 24 Jun 2019. 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?
AUC0-∞,AM833: the area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after single dose (time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)). 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 24 Jun 2019.