Metabolism and Nutrition DisorderPhase 1NCT02941042
A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity.
A Phase 1 study testing NNC9204-1177 in people with Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects being Overweight or with Obesity Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolism and Nutrition Disorder, Obesity
- What is being tested?
- NNC9204-1177
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2016to 30 Sep 2017
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, aged 18-55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive) at screening
Who cannot join
- 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) (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) risk above 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), and/or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
Baltimore, Maryland, 21225
About this study
Official title: This Trial is Conducted in the United State of America. The Aim of This Trial is to Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity
Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects being Overweight or with Obesity
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Being tested
- NNC9204-1177, Placebo
- Medical subject headings
- Nutrition Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC9204-1177Drug
A single dose administered subcutaneously ( s.c. under the skin)
PlaceboDrug
A single dose administered subcutaneously ( s.c. under the skin)
| Study group | Role | What they receive |
|---|---|---|
| NNC9204-1177 | Experimental | Not described Receives: Drug: NNC9204-1177 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAEs)
Measured: From time of dosing (day 1) until completion of the follow-up visit (day 39)
Secondary outcomes (5)
Area under the NNC9204-1177 serum concentration-time curve
Measured: From 0 to 168 hours after a single s.c. dose
Maximum serum concentration of NNC9204-1177
Sampling was done day 1, 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 39
Measured: From time of dosing (day 1) until completion of the follow-up visit (day 39)
Time to maximum serum concentration of NNC9204-1177
Sampling was done day 1, 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 39
Measured: From time of dosing (day 1) until completion of the follow-up visit (day 39)
Change in body weight
Measured: Day 1, day 39
Change in QT interval corrected using the Fridericia formula (QTcF)
Measured: Day 1, day 39
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start10 Oct 2016
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolism and Nutrition DisorderStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941042
- Sponsor's protocol ID
- NN9277-4258
- Other IDs
- U1111-1173-8190
- Status last verified
- Sep 2018
- First submitted
- 7 Oct 2016
- Last updated
- 5 Sep 2018
- 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 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This Trial is Conducted in the United State of America. The Aim of This Trial is to Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity
- ClinicalTrials.gov ID
- NCT02941042
- Acronym / sponsor ID
- NN9277-4258
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 21 Oct 2016 (estimated)
- 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.
Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects being Overweight or with Obesity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC9204-1177 | Experimental | Drug: NNC9204-1177 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male, aged 18-55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive) at screening
Key exclusion criteria (3 listed)
- 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) (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) risk above 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), and/or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product
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 |
|---|---|---|
| NNC9204-1177A single dose administered subcutaneously ( s.c. under the skin) | Drug | NNC9204-1177 |
| PlaceboA single dose administered subcutaneously ( s.c. under the skin) | Drug | Placebo |
Primary outcome
Number of treatment emergent adverse events (TEAEs)
Time frame: From time of dosing (day 1) until completion of the follow-up visit (day 39)
5 secondary outcomes
Area under the NNC9204-1177 serum concentration-time curve
Time frame: From 0 to 168 hours after a single s.c. dose
Maximum serum concentration of NNC9204-1177
Time frame: From time of dosing (day 1) until completion of the follow-up visit (day 39)
Time to maximum serum concentration of NNC9204-1177
Time frame: From time of dosing (day 1) until completion of the follow-up visit (day 39)
Change in body weight
Time frame: Day 1, day 39
Change in QT interval corrected using the Fridericia formula (QTcF)
Time frame: Day 1, day 39
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 5 Sep 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 NNC9204-1177 in people with Metabolism and Nutrition Disorder 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 5 Sep 2018. 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?
Number of treatment emergent adverse events (TEAEs) (time frame: From time of dosing (day 1) until completion of the follow-up visit (day 39)). 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 5 Sep 2018.