Metabolism and Nutrition DisorderPhase 1NCT02568306
A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses and Multiple Doses of NNC0165-1562 in Overweight to Obese But Otherwise Healthy Subjects
A Phase 1 study testing NNC0165-1562 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. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) for single doses and multiple doses of NNC0165-1562 in overweight to obese but otherwise healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism and Nutrition Disorder, Obesity
- What is being tested?
- NNC0165-1562
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2015to 7 Feb 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part I (SD):
- 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). Overweight should be due to excess of adipose tissue, as judged by the investigator
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator
- Part II (MD):
- Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 27.0 and 39.9 kg/m^2 (both inclusive). Overweight should be due to excess of adipose tissue, as judged by the investigator
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator
Who cannot join
- Any clinically significant weight change (at least 5% self-reported change during the previous 3 months), dieting attempts (e.g. participation in an organised weight reduction programme within the last 3 months), prior obesity surgery, or medications affecting body weight within 3 months prior to screening
- Male subjects who are not 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 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
- Female subjects who are of child bearing potential (pre-menopausal and not surgically sterilised) and are sexually active with male partner(s) who are not surgically sterilised (vasectomy) and are not using highly effective contraceptive methods (Pearl Index 1%,such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), and/or are pregnant, breast-feeding or intend to become pregnant) (applicable to Part II (MD) only)
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
Tempe, Arizona, 85283
About this study
Official title: A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses and Multiple Doses of NNC0165-1562 in Overweight to Obese But Otherwise Healthy Subjects.
This trial is conducted in the United States of America. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) for single doses and multiple doses of NNC0165-1562 in overweight to obese but otherwise healthy subjects.
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Being tested
- NNC0165-1562, 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.
NNC0165-1562Drug
Administered subcutaneously (s.c., under the skin) single dose [SD] or multiple dose [MD] with daily dosing.
placeboDrug
Administered subcutaneously (s.c., under the skin) single dose [SD]) or multiple dose [MD] with daily dosing.
| Study group | Role | What they receive |
|---|---|---|
| NNC0165-1562 | Experimental | Not described Receives: Drug: NNC0165-1562 |
| 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), Part I (SD)
Measured: From time of dosing (Day1) until completion of the follow-up visit (Day 29)
Number of TEAEs, Part II (MD)
Measured: From time of dosing (Day 1) until completion of the follow-up visit (Day 85)
Secondary outcomes (6)
The area under the NNC0165-1562 plasma concentration-time curve, Part I (SD)
Measured: From time 0 to 24 hours after a single s.c. dose. From baseline (Day 1) until the follow-up visit (Day 29)
The maximum plasma concentration of NNC0165-1562 after a single s.c. dose, Part I (SD)
Measured: From baseline (Day 1) until the follow-up visit (Day 29)
The time to maximum plasma concentration of NNC0165-1562 after a single s.c.dose, Part I (SD)
Measured: From baseline (Day 1) until the follow-up visit (Day 29)
The area under the NNC0165-1562 plasma concentration-time curve, Part II (MD)
Measured: From time 0 to 24 hours at steady state. From baseline (Day 1) until the follow-up visit (Day 85)
The maximum plasma concentration of NNC0165-1562 at steady state, Part II (MD)
Measured: From baseline (Day 1) until the follow-up visit (Day 85)
The time to maximum plasma concentration of NNC0165-1562 at steady state, Part II (MD)
Measured: From baseline (Day 1) until the follow-up visit (Day 85)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study start5 Oct 2015
- Primary completion7 Feb 2017
- Study completion7 Feb 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 93 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
- NCT02568306
- Sponsor's protocol ID
- NN9747-4194
- Other IDs
- U1111-1164-6546
- Status last verified
- Jul 2018
- First submitted
- 2 Oct 2015
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses and Multiple Doses of NNC0165-1562 in Overweight to Obese But Otherwise Healthy Subjects.
- ClinicalTrials.gov ID
- NCT02568306
- Acronym / sponsor ID
- NN9747-4194
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2015 (actual)
- Primary completion
- 7 Feb 2017 (actual)
- Study completion
- 7 Feb 2017 (actual)
- First posted
- 5 Oct 2015 (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. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) for single doses and multiple doses of NNC0165-1562 in overweight to obese but otherwise healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0165-1562 | Experimental | Drug: NNC0165-1562 |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Part I (SD):
- 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). Overweight should be due to excess of adipose tissue, as judged by the investigator
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator
- Part II (MD):
Key exclusion criteria (3 listed)
- Any clinically significant weight change (at least 5% self-reported change during the previous 3 months), dieting attempts (e.g. participation in an organised weight reduction programme within the last 3 months), prior obesity surgery, or medications affecting body weight within 3 months prior to screening
- Male subjects who are not 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 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
- Female subjects who are of child bearing potential (pre-menopausal and not surgically sterilised) and are sexually active with male partner(s) who are not surgically sterilised (vasectomy) and are not using highly effective contraceptive methods (Pearl Index 1%,such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), and/or are pregnant, breast-feeding or intend to become pregnant) (applicable to Part II (MD) only)
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 |
|---|---|---|
| NNC0165-1562Administered subcutaneously (s.c., under the skin) single dose [SD] or multiple dose [MD] with daily dosing. | Drug | NNC0165-1562 |
| placeboAdministered subcutaneously (s.c., under the skin) single dose [SD]) or multiple dose [MD] with daily dosing. | Drug | Placebo |
Primary outcome
Number of treatment emergent adverse events (TEAEs), Part I (SD)
Time frame: From time of dosing (Day1) until completion of the follow-up visit (Day 29)
Number of TEAEs, Part II (MD)
Time frame: From time of dosing (Day 1) until completion of the follow-up visit (Day 85)
6 secondary outcomes
The area under the NNC0165-1562 plasma concentration-time curve, Part I (SD)
Time frame: From time 0 to 24 hours after a single s.c. dose. From baseline (Day 1) until the follow-up visit (Day 29)
The maximum plasma concentration of NNC0165-1562 after a single s.c. dose, Part I (SD)
Time frame: From baseline (Day 1) until the follow-up visit (Day 29)
The time to maximum plasma concentration of NNC0165-1562 after a single s.c.dose, Part I (SD)
Time frame: From baseline (Day 1) until the follow-up visit (Day 29)
The area under the NNC0165-1562 plasma concentration-time curve, Part II (MD)
Time frame: From time 0 to 24 hours at steady state. From baseline (Day 1) until the follow-up visit (Day 85)
The maximum plasma concentration of NNC0165-1562 at steady state, Part II (MD)
Time frame: From baseline (Day 1) until the follow-up visit (Day 85)
The time to maximum plasma concentration of NNC0165-1562 at steady state, Part II (MD)
Time frame: From baseline (Day 1) until the follow-up visit (Day 85)
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 13 Jul 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 NNC0165-1562 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 8 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 13 Jul 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), Part I (SD) (time frame: From time of dosing (Day1) until completion of the follow-up visit (Day 29)). 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 13 Jul 2018.