Metabolism and Nutrition DisorderPhase 1NCT03015207
First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity
A Phase 1 study testing NNC0194-0499 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 this trial is to investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the body) of NNC0194-0499 in Male Subjects with Overweight or Obesity. Read more about this study
- Who is it for?
- Ages 22 to 55 years, men only
- Conditions the study is for
- Metabolism and Nutrition Disorder, Obesity
- What is being tested?
- NNC0194-0499
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2017to 26 Oct 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 22 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male, aged 22-55 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 adipose tissue, as judged by the investigator
Who cannot join
- Any concomitant illness or disorder, which in the investigator's opinion might jeopardise the subject's safety or compliance with the protocol
- Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD according to ACC/AHA (American College of Cardiology /American Heart Association) 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) 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 (visit 1) until 3 months following administration of the investigational medical product
- Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening, with the exception of occasional use of acetaminophen, ibuprofen or acetylsalicylic acid
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
San Antonio, Texas, 78209
About this study
Official title: A Randomised, Double-blinded, Single-dose, Dose-escalation, First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity
This trial is conducted in The United States of America. The aim of this trial is to investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Being tested
- NNC0194-0499, 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.
NNC0194-0499Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| NNC0194-0499 | Experimental | Injected s.c. /subcutaneously (under the skin) Receives: Drug: NNC0194-0499 |
| Placebo | Placebo comparator | Injected s.c. /subcutaneously (under the skin) 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 administration of NNC0194-0499 (day 1) to completion of the post-treatment period at follow-up (day 36)
Secondary outcomes (3)
The area under the NNC0194-0499 serum concentration-time curve after a single subcutaneous administration
Measured: From pre-dose (day 1) until the followup (day 36)
The maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration
Measured: From pre-dose (day 1) until the followup (day 36)
The time to maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration
Measured: From pre-dose (day 1) until the followup (day 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start6 Jan 2017
- Primary completion26 Oct 2017
- Study completion26 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 56 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
- NCT03015207
- Sponsor's protocol ID
- NN9499-4277
- Other IDs
- U1111-1181-9045
- Status last verified
- Sep 2018
- First submitted
- 6 Jan 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Dahl K, Friedrichsen MH, Ribel-Madsen R, Hansen JS, Clausen JO, Axelsen M, Palle MS, Lippert SL, Bjorkdahl O, Toubro S, Key C, Andersen B. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Long-Acting FGF21 Analog Zalfermin. Clin Transl Sci. 2025 Dec;18(12):e70435. doi: 10.1111/cts.70435.
PubMed 41351276
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
- A Randomised, Double-blinded, Single-dose, Dose-escalation, First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT03015207
- Acronym / sponsor ID
- NN9499-4277
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 26 Oct 2017 (actual)
- Study completion
- 26 Oct 2017 (actual)
- First posted
- 9 Jan 2017 (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 this trial is to investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0194-0499 | Experimental | Drug: NNC0194-0499Injected s.c. /subcutaneously (under the skin) |
| Placebo | Placebo comparator | Drug: PlaceboInjected s.c. /subcutaneously (under the skin) |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male, aged 22-55 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 adipose tissue, as judged by the investigator
Key exclusion criteria (4 listed)
- Any concomitant illness or disorder, which in the investigator's opinion might jeopardise the subject's safety or compliance with the protocol
- Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD according to ACC/AHA (American College of Cardiology /American Heart Association) 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) 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 (visit 1) until 3 months following administration of the investigational medical product
- Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening, with the exception of occasional use of acetaminophen, ibuprofen or acetylsalicylic acid
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 |
|---|---|---|
| NNC0194-0499 | Drug | NNC0194-0499 |
| Placebo | Drug | Placebo |
Primary outcome
Number of treatment-emergent adverse events (TEAEs)
Time frame: From time of administration of NNC0194-0499 (day 1) to completion of the post-treatment period at follow-up (day 36)
3 secondary outcomes
The area under the NNC0194-0499 serum concentration-time curve after a single subcutaneous administration
Time frame: From pre-dose (day 1) until the followup (day 36)
The maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration
Time frame: From pre-dose (day 1) until the followup (day 36)
The time to maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration
Time frame: From pre-dose (day 1) until the followup (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 5 Sep 2018.
- Derived from this study: PubMed 41351276Dahl K, Friedrichsen MH, Ribel-Madsen R, Hansen JS, Clausen JO, Axelsen M, Palle MS, Lippert SL, Bjorkdahl O, Toubro S, Key C, Andersen B. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Long-Acting FGF21 Analog Zalfermin. Clin Transl Sci. 2025 Dec;18(12):e70435. doi: 10.1111/cts.70435.
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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 NNC0194-0499 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 4 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 administration of NNC0194-0499 (day 1) to completion of the post-treatment period at follow-up (day 36)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03015207, which also lists 1 linked publication.
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.