OverweightPhase 1NCT04209049
A Research Study Looking Into Blood Levels of NNC0174-0833 in People With Normal and Impaired Kidney Function
A Phase 1 study testing NNC0174-0833 in people with Overweight and Obesity, run by Novo Nordisk A/S at 2 sites in United States.
Trial summary
The study looks at the blood levels of a new study medicine in people with normal and impaired kidney function. Participants will get the study medicine called NNC0174-0833. This is an experimental medicine and has not been approved by the US FDA. It is being developed as a new medicine for weight management. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- NNC0174-0833
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2020to 5 Jan 2021
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female of non-childbearing potential, aged 18-80 years (both inclusive) at the time of signing informed consent.
- Meeting the pre-defined GFR criteria using estimated GFR (eGFR) based on serum creatinine for any of the renal function groups:
- For subjects with normal renal function: eGFR of equal to or above 90 mL/min
- For patients with mild renal impairment: eGFR of 60-89 mL/min
- For patients with moderate renal impairment: eGFR of 30-59 mL/min
- For patients with severe renal impairment: eGFR of <30 mL/min not requiring dialysis
Who cannot join
- Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
- Use of prescription or non-prescription drugs, or non-routine vitamins, which at the investigators judgement may affect subject safety or the results of the trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Novo Nordisk Investigational Site
Miami, Florida, 33136
Novo Nordisk Investigational Site
Orlando, Florida, 32806
About this study
Official title: An Open-label Trial Investigating the Pharmacokinetics and the Tolerability of NNC0174-0833 in Subjects With Normal Renal Function and Impaired Renal Function
The study looks at the blood levels of a new study medicine in people with normal and impaired kidney function. Participants will get the study medicine called NNC0174-0833. This is an experimental medicine and has not been approved by the US FDA. It is being developed as a new medicine for weight management. Participants will get 1 injection of the study medicine by a study nurse at the clinic. The injection will be with a needle in a skin fold in the stomach area. The study will last for about 9 weeks. Participants will have about 7 visits with the study staff or the doctor. At the visits, participants will have clinical checks done and blood samples taken. Participants will be collecting their urine several times during the study. Participants will be asked about their health, medical history and habits. People who are already in another research study cannot take part. Only women who are not able to become pregnant can take part in the study. Only men who do not plan to father a child during the study or 6 weeks following the dose administration can take part in the study.
- Conditions
- Overweight, Obesity
- Being tested
- NNC0174-0833
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0174-0833Drug
A single subcutaneous (s.c., under the skin) dose of 0.6 mg NNC0174-0833.
| Study group | Role | What they receive |
|---|---|---|
| Normal renal function | Experimental | All subjects will receive one dose of NNC0174-0833. Receives: Drug: NNC0174-0833 |
| Mild renal impairment | Experimental | All subjects will receive one dose of NNC0174-0833. Receives: Drug: NNC0174-0833 |
| Moderate renal impairment | Experimental | All subjects will receive one dose of NNC0174-0833. Receives: Drug: NNC0174-0833 |
| Severe renal impairment | Experimental | All subjects will receive one dose of NNC0174-0833. Receives: Drug: NNC0174-0833 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma NNC0174-0833 concentration-time curve after a single dose
nmol*h/L
Measured: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, Day 36)
Secondary outcomes (3)
Maximum observed plasma NNC0174-0833 concentration after a single dose
nmol/L
Measured: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (visit 7, Day 36)
Time to maximum observed plasma NNC0174-0833 concentration after a single dose
hours
Measured: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, Day 36)
Number of treatment emergent adverse events (TEAEs)
Number of events
Measured: From time of trial product administration (Visit 2, Day 1) until completion of the end of trial visit (Visit 7, Day 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start15 Jan 2020
- Primary completion5 Jan 2021
- Study completion5 Jan 2021
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 OverweightStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209049
- Sponsor's protocol ID
- NN9838-4518
- Other IDs
- U1111-1228-9001
- Status last verified
- Jan 2021
- First submitted
- 19 Dec 2019
- Last updated
- 26 Jan 2021
- 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
Publications
Nielsen MJF, Becker NP, Duus HHH, Kirkeby K, Kupcova V, Lauenborg BW, Low B, Svolgaard O, Witten L. Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide. Clin Pharmacokinet. 2026 Jul;65(7):1087-1099. doi: 10.1007/s40262-026-01654-0. Epub 2026 Jun 1.
PubMed 42228334
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Trial Investigating the Pharmacokinetics and the Tolerability of NNC0174-0833 in Subjects With Normal Renal Function and Impaired Renal Function
- ClinicalTrials.gov ID
- NCT04209049
- Acronym / sponsor ID
- NN9838-4518
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 23 Dec 2019 (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.
The study looks at the blood levels of a new study medicine in people with normal and impaired kidney function. Participants will get the study medicine called NNC0174-0833. This is an experimental medicine and has not been approved by the US FDA. It is being developed as a new medicine for weight management. Participants will get 1 injection of the study medicine by a study nurse at the clinic. The injection will be with a needle in a skin fold in the stomach area. The study will last for about 9 weeks. Participants will have about 7 visits with the study staff or the doctor. At the visits, participants will have clinical checks done and blood samples taken. Participants will be collecting their urine several times during the study. Participants will be asked about their health, medical history and habits. People who are already in another research study cannot take part. Only women who are not able to become pregnant can take part in the study. Only men who do not plan to father a child during the study or 6 weeks following the dose administration can take part in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal renal function | Experimental | Drug: NNC0174-0833All subjects will receive one dose of NNC0174-0833. |
| Mild renal impairment | Experimental | Drug: NNC0174-0833All subjects will receive one dose of NNC0174-0833. |
| Moderate renal impairment | Experimental | Drug: NNC0174-0833All subjects will receive one dose of NNC0174-0833. |
| Severe renal impairment | Experimental | Drug: NNC0174-0833All subjects will receive one dose of NNC0174-0833. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female of non-childbearing potential, aged 18-80 years (both inclusive) at the time of signing informed consent.
- Meeting the pre-defined GFR criteria using estimated GFR (eGFR) based on serum creatinine for any of the renal function groups:
- For subjects with normal renal function: eGFR of equal to or above 90 mL/min
- For patients with mild renal impairment: eGFR of 60-89 mL/min
- For patients with moderate renal impairment: eGFR of 30-59 mL/min
Key exclusion criteria (2 listed)
- Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
- Use of prescription or non-prescription drugs, or non-routine vitamins, which at the investigators judgement may affect subject safety or the results of the trial.
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 |
|---|---|---|
| NNC0174-0833A single subcutaneous (s.c., under the skin) dose of 0.6 mg NNC0174-0833. | Drug | Mild renal impairment, Moderate renal impairment, Normal renal function, Severe renal impairment |
Primary outcome
Area under the plasma NNC0174-0833 concentration-time curve after a single dose
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, Day 36)
nmol*h/L
3 secondary outcomes
Maximum observed plasma NNC0174-0833 concentration after a single dose
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (visit 7, Day 36)
Time to maximum observed plasma NNC0174-0833 concentration after a single dose
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, Day 36)
Number of treatment emergent adverse events (TEAEs)
Time frame: From time of trial product administration (Visit 2, Day 1) until completion of the end of trial visit (Visit 7, 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 26 Jan 2021.
- Derived from this study: PubMed 42228334Nielsen MJF, Becker NP, Duus HHH, Kirkeby K, Kupcova V, Lauenborg BW, Low B, Svolgaard O, Witten L. Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide. Clin Pharmacokinet. 2026 Jul;65(7):1087-1099. doi: 10.1007/s40262-026-01654-0. Epub 2026 Jun 1.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Overweight
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
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
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
2 sites 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 Overweight and Obesity, run by Novo Nordisk A/S at 2 sites 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 6 inclusion and 2 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 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Area under the plasma NNC0174-0833 concentration-time curve after a single dose (time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, 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 NCT04209049, 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 26 Jan 2021.