Metabolism and Nutrition DisorderPhase 1NCT02300844
Investigation on Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0174-0833 in Normal Weight, Overweight to Obese But Otherwise Healthy Male Subjects
A Phase 1 study testing NNC0174-0833 in people with Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability and pharmacokinetics of single doses of NNC0174-0833 in normal weight, overweight to obese but otherwise healthy male subjects. Read more about this study
- Who is it for?
- Ages 22 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolism and Nutrition Disorder, Obesity
- 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
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2014to 21 Mar 2016
- 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 22 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal weight, Overweight or obese (Body Mass Index [BMI]) between or equal to 20.0 and 35.0 kg/m^2 but otherwise healthy men
- Age between or equal to 22 and 64 years at the time of signing informed consent
Who cannot join
- History of, or presence of, cancer, diabetes or any clinically significant cardiovascular,respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders including sleep apnoea, as judged by the investigator
- Subjects with history of, or presence of, a disease being associated with impaired calcium homeostasis and/or increased bone turnover (e.g. Paget´s disease, osteoporosis)
- Male subjects of reproductive age who are not using a highly effective physical barrier method of contraception (sexual abstinence, or condom with spermicidal foam/gel/film/cream) combined with a method with Pearl Index less than 1% for their nonpregnant partner(s) (such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices or diaphragm+spermicide, or surgical sterilisation or post-menopausal) and/or who intend to donate sperm in the period from start of Visit 2 up to 3 months following the administration of the investigational medicinal product
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
Overland Park, Kansas, 66212
About this study
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability and pharmacokinetics of single doses of NNC0174-0833 in normal weight, overweight to obese but otherwise healthy male subjects.
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Being tested
- NNC0174-0833, 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.
NNC0174-0833Drug
Subjects will receive a single s.c. (subcutaneous/under the skin) dose of NNC0174-0833.
Up to nine dose levels of single s.c. doses of NNC0174-0833 are planned to be investigated.
placeboDrug
Subjects will receive a single s.c. (subcutaneousl/under the skin) dose.
| Study group | Role | What they receive |
|---|---|---|
| NNC0174-0833 10 mg/mL | Experimental | Not described Receives: Drug: NNC0174-0833 |
| 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 the time of dosing (Day 1) until completion of the post treatment follow-up visit (Day 43-50)
Secondary outcomes (3)
Area under the NNC0174-0833 plasma concentration-time curve
Measured: Prior to the initial dose on day 1 and 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, 72, 96, 120, 168, 240, 336, 504, and 1008 hours post-dose
Maximum concentration of NNC0174-0833 in plasma
Measured: Prior to the initial dose on day 1 and 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, 72, 96, 120, 168, 240, 336, 504, and 1008 hours post-dose
Time to maximum concentration of NNC0174-0833 in plasma
Measured: Prior to the initial dose on day 1 and 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, 72, 96, 120, 168, 240, 336, 504, and 1008 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study start1 Dec 2014
- Primary completion21 Mar 2016
- Study completion21 Mar 2016
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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300844
- Sponsor's protocol ID
- NN9838-3993
- Other IDs
- U1111-1131-7160
- Status last verified
- Jan 2018
- First submitted
- 21 Nov 2014
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0174-0833 in Normal Weight, Overweight to Obese But Otherwise Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02300844
- Acronym / sponsor ID
- NN9838-3993
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 21 Mar 2016 (actual)
- Study completion
- 21 Mar 2016 (actual)
- First posted
- 25 Nov 2014 (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.
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability and pharmacokinetics of single doses of NNC0174-0833 in normal weight, overweight to obese but otherwise healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0174-0833 10 mg/mL | Experimental | Drug: NNC0174-0833 |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 22 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normal weight, Overweight or obese (Body Mass Index [BMI]) between or equal to 20.0 and 35.0 kg/m^2 but otherwise healthy men
- Age between or equal to 22 and 64 years at the time of signing informed consent
Key exclusion criteria (3 listed)
- History of, or presence of, cancer, diabetes or any clinically significant cardiovascular,respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders including sleep apnoea, as judged by the investigator
- Subjects with history of, or presence of, a disease being associated with impaired calcium homeostasis and/or increased bone turnover (e.g. Paget´s disease, osteoporosis)
- Male subjects of reproductive age who are not using a highly effective physical barrier method of contraception (sexual abstinence, or condom with spermicidal foam/gel/film/cream) combined with a method with Pearl Index less than 1% for their nonpregnant partner(s) (such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices or diaphragm+spermicide, or surgical sterilisation or post-menopausal) and/or who intend to donate sperm in the period from start of Visit 2 up to 3 months following the administration of the investigational medicinal 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 |
|---|---|---|
| NNC0174-0833Subjects will receive a single s.c. (subcutaneous/under the skin) dose of NNC0174-0833. Up to nine dose levels of single s.c. doses of NNC0174-0833 are planned to be investigated. | Drug | NNC0174-0833 10 mg/mL |
| placeboSubjects will receive a single s.c. (subcutaneousl/under the skin) dose. | Drug | Placebo |
Primary outcome
Number of treatment emergent adverse events (TEAEs)
Time frame: From the time of dosing (Day 1) until completion of the post treatment follow-up visit (Day 43-50)
3 secondary outcomes
Area under the NNC0174-0833 plasma concentration-time curve
Time frame: Prior to the initial dose on day 1 and 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, 72, 96, 120, 168, 240, 336, 504, and 1008 hours post-dose
Maximum concentration of NNC0174-0833 in plasma
Time frame: Prior to the initial dose on day 1 and 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, 72, 96, 120, 168, 240, 336, 504, and 1008 hours post-dose
Time to maximum concentration of NNC0174-0833 in plasma
Time frame: Prior to the initial dose on day 1 and 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, 72, 96, 120, 168, 240, 336, 504, and 1008 hours post-dose
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 Jan 2018.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 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 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 24 Jan 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 the time of dosing (Day 1) until completion of the post treatment follow-up visit (Day 43-50)). 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 Jan 2018.