Metabolism and Nutrition DisorderPhase 1NCT03095807
Investigation of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity
A Phase 1 study testing NNC9204-1706 A 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 assess the safety and tolerability of single doses of NNC9204-1706 administered subcutaneously in male subjects being overweight or with obesity. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Metabolism and Nutrition Disorder, Obesity
- What is being tested?
- NNC9204-1706 A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2017to 31 Aug 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
- No healthy volunteers
- Adult
Who may be able to join
- Male subjects 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. Overweight should be due to excess of adipose tissue, as judged by the investigator
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 equal to or above 5%
- Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) and 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: Investigation on Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity
This trial is conducted in the United States of America (USA). The aim of this trial is to assess the safety and tolerability of single doses of NNC9204-1706 administered subcutaneously in male subjects being overweight or with obesity.
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Being tested
- NNC9204-1706 A, 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.
NNC9204-1706 ADrug
Administered subcutaneously (s.c., under the skin) Up to 7 dose cohorts will be investigated.
PlaceboDrug
Administered subcutaneously (s.c., under the skin)
| Study group | Role | What they receive |
|---|---|---|
| NNC9204-1706 A | Experimental | Not described Receives: Drug: NNC9204-1706 A |
| 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)
Count and % of events
Measured: From the time of dosing (Day 1) and until completion of the post-treatment follow-up visit (Days 10-13)
Secondary outcomes (12)
Area under the NNC9204-1706 plasma concentration-time curve
Calculated based on NNC9204-1706 measured in blood.
Measured: Day 1- Day 7
Area under the NNC9204-1706 plasma concentration-time curve (0-24h)
Calculated based on NNC9204-1706 measured in blood.
Measured: Day 1- Day 7
Area under the NNC9204-1706 plasma concentration-time curve (0- to last quantifiable sample)
Calculated based on NNC9204-1706 measured in blood.
Measured: Day 1- Day 7
Maximal observed concentration of the NNC9204-1706 plasma concentration curve
Calculated based on NNC9204-1706 measured in blood.
Measured: Day 1- Day 7
Time to observed maximum concentration of NNC9204-1706 in plasma
Calculated based on NNC9204-1706 measured in blood.
Measured: Day 1- Day 7
Terminal half-life of NNC9204-1706
Calculated based on NNC9204-1706 measured in blood.
Measured: Day 1- Day 7
Mean residence time of NNC9204-1706
Calculated based on NNC9204-1706 measured in blood.
Measured: Day 1- Day 7
The apparent total plasma clearance of NNC9204-1706
Calculated based on NNC9204-1706 measured in blood.
Measured: Day 1- Day 7
The apparent volume of distribution of NNC9204-1706
Calculated based on NNC9204-1706 measured in blood.
Measured: Day 1- Day 7
Changes in Body weight
Measured in kg and/or %
Measured: Day 1, Days 10-13
Number of injection-site reactions
Count of reactions
Measured: From the time of dosing (Day 1) to the follow-up visit (Days 10-13)
Number of hypoglycaemic episodes
Count of episodes
Measured: from time of dosing (Day 1) to the follow-up visit (Days 10-13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start20 Mar 2017
- Primary completion31 Aug 2017
- Study completion31 Aug 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 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
- NCT03095807
- Sponsor's protocol ID
- NN9423-4302
- Other IDs
- U1111-1177-7821
- Status last verified
- Oct 2018
- First submitted
- 24 Mar 2017
- Last updated
- 5 Oct 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 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity
- ClinicalTrials.gov ID
- NCT03095807
- Acronym / sponsor ID
- NN9423-4302
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 30 Mar 2017 (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 trial is conducted in the United States of America (USA). The aim of this trial is to assess the safety and tolerability of single doses of NNC9204-1706 administered subcutaneously in male subjects being overweight or with obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC9204-1706 A | Experimental | Drug: NNC9204-1706 A |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male subjects 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. Overweight should be due to excess of adipose tissue, as judged by the investigator
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 equal to or above 5%
- Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) and 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 |
|---|---|---|
| NNC9204-1706 AAdministered subcutaneously (s.c., under the skin) Up to 7 dose cohorts will be investigated. | Drug | NNC9204-1706 A |
| PlaceboAdministered subcutaneously (s.c., under the skin) | Drug | Placebo |
Primary outcome
Number of treatment-emergent adverse events (TEAEs)
Time frame: From the time of dosing (Day 1) and until completion of the post-treatment follow-up visit (Days 10-13)
Count and % of events
12 secondary outcomes
Area under the NNC9204-1706 plasma concentration-time curve
Time frame: Day 1- Day 7
Area under the NNC9204-1706 plasma concentration-time curve (0-24h)
Time frame: Day 1- Day 7
Area under the NNC9204-1706 plasma concentration-time curve (0- to last quantifiable sample)
Time frame: Day 1- Day 7
Maximal observed concentration of the NNC9204-1706 plasma concentration curve
Time frame: Day 1- Day 7
Time to observed maximum concentration of NNC9204-1706 in plasma
Time frame: Day 1- Day 7
Terminal half-life of NNC9204-1706
Time frame: Day 1- Day 7
Mean residence time of NNC9204-1706
Time frame: Day 1- Day 7
The apparent total plasma clearance of NNC9204-1706
Time frame: Day 1- Day 7
The apparent volume of distribution of NNC9204-1706
Time frame: Day 1- Day 7
Changes in Body weight
Time frame: Day 1, Days 10-13
Number of injection-site reactions
Time frame: From the time of dosing (Day 1) to the follow-up visit (Days 10-13)
Number of hypoglycaemic episodes
Time frame: from time of dosing (Day 1) to the follow-up visit (Days 10-13)
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 Oct 2018.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Metabolism and Nutrition Disorder
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
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 NNC9204-1706 A 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 Oct 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) and until completion of the post-treatment follow-up visit (Days 10-13)). 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 Oct 2018.