Metabolism and Nutrition DisorderPhase 1NCT02870231
Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With Obesity
A Phase 1 study testing NNC9204-0530 and liraglutide in people with Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 2 sites 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, PK (the exposure of the trial drug in the body) and PD (the effect of the investigated drug on the body) for Multiple Doses of NNC9204-0530 in Combination with Liraglutide in Male and Female Subjects… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Metabolism and Nutrition Disorder, Obesity
- What is being tested?
- NNC9204-0530 and liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Aug 2016to 3 Sep 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
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index between 25.0 and 39.9 kg/m^2 (both inclusive) at screening.
- Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent
Who cannot join
- Any clinically significant weight change (equal or above 5% self-reported change) or dieting attempts (e.g. participation in an organized weight reduction program within the last 90 days prior to screening
- Any prior obesity surgery or currently present gastrointestinal implant.
- Thyroid-stimulating hormone (TSH) values outside 0.4-6.0 mIU/L
- Glycosylated haemoglobin (HbA1c)above or equal to 6.5% or in Système International (SI) units 48 mmol/mol
- Abnormal ECG (electrocardiogram) results including 2nd or 3rd degree AV-block, prolongation of the QRS complex above 120 ms, or the QTcF interval above 430 ms (males) or above 450 ms (females), or other clinically relevant abnormal results, as judged by the investigator
- A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
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- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
- Calcitonin above or equal to 50 ng/L
- History of pancreatitis (acute or chronic)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Novo Nordisk Investigational Site
Lincoln, Nebraska, 68502
Novo Nordisk Investigational Site
Tempe, Arizona, 85283
About this study
Official title: A Multiple Dose Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With Obesity
This trial is conducted in the United States of America. The aim of this trial is to investigate Safety, Tolerability, PK (the exposure of the trial drug in the body) and PD (the effect of the investigated drug on the body) for Multiple Doses of NNC9204-0530 in Combination with Liraglutide in Male and Female Subjects being Overweight or with Obesity
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Being tested
- NNC9204-0530, liraglutide, 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.
NNC9204-0530Drug
Once-daily subcutaneous (s.c., under the skin) administration.
liraglutideDrug
Once-daily subcutaneous (s.c., under the skin) administration.
placeboDrug
Once-daily subcutaneous (s.c., under the skin) administration
| Study group | Role | What they receive |
|---|---|---|
| NNC9204-0530 / Placebo and Liraglutide 1.8 | Experimental | Not described Receives: Drug: NNC9204-0530; Drug: liraglutide; Drug: placebo |
| NNC9204-0530 /Placebo and Liraglutide 3.0 | Active comparator | Not described Receives: Drug: NNC9204-0530; Drug: liraglutide; 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
Measured: Day 1-112
Secondary outcomes (3)
Area under the NNC9204-0530 serum concentration-time curve
Measured: Day 84-112
Time to maximum serum concentration of NNC9204-0530
Measured: Day 84-112
Change in HbA1C
Measured: Day -1, Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study start18 Aug 2016
- Primary completion3 Sep 2017
- Study completion3 Sep 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 187 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
- NCT02870231
- Sponsor's protocol ID
- NN9030-4130
- Other IDs
- U1111-1175-7040
- Status last verified
- Sep 2018
- First submitted
- 12 Aug 2016
- Last updated
- 5 Sep 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 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With Obesity
- ClinicalTrials.gov ID
- NCT02870231
- Acronym / sponsor ID
- NN9030-4130
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2016 (actual)
- Primary completion
- 3 Sep 2017 (actual)
- Study completion
- 3 Sep 2017 (actual)
- First posted
- 17 Aug 2016 (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, PK (the exposure of the trial drug in the body) and PD (the effect of the investigated drug on the body) for Multiple Doses of NNC9204-0530 in Combination with Liraglutide in Male and Female Subjects being Overweight or with Obesity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC9204-0530 / Placebo and Liraglutide 1.8 | Experimental | Drug: NNC9204-0530, Drug: liraglutide, Drug: placebo |
| NNC9204-0530 /Placebo and Liraglutide 3.0 | Active comparator | Drug: NNC9204-0530, Drug: liraglutide, Drug: placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index between 25.0 and 39.9 kg/m^2 (both inclusive) at screening.
- Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent
Key exclusion criteria (9 listed)
- Any clinically significant weight change (equal or above 5% self-reported change) or dieting attempts (e.g. participation in an organized weight reduction program within the last 90 days prior to screening
- Any prior obesity surgery or currently present gastrointestinal implant.
- Thyroid-stimulating hormone (TSH) values outside 0.4-6.0 mIU/L
- Glycosylated haemoglobin (HbA1c)above or equal to 6.5% or in Système International (SI) units 48 mmol/mol
- Abnormal ECG (electrocardiogram) results including 2nd or 3rd degree AV-block, prolongation of the QRS complex above 120 ms, or the QTcF interval above 430 ms (males) or above 450 ms (females), or other clinically relevant abnormal results, as judged by the investigator
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 |
|---|---|---|
| NNC9204-0530Once-daily subcutaneous (s.c., under the skin) administration. | Drug | NNC9204-0530 / Placebo and Liraglutide 1.8, NNC9204-0530 /Placebo and Liraglutide 3.0 |
| liraglutideOnce-daily subcutaneous (s.c., under the skin) administration. | Drug | NNC9204-0530 / Placebo and Liraglutide 1.8, NNC9204-0530 /Placebo and Liraglutide 3.0 |
| placeboOnce-daily subcutaneous (s.c., under the skin) administration | Drug | NNC9204-0530 / Placebo and Liraglutide 1.8, NNC9204-0530 /Placebo and Liraglutide 3.0 |
Primary outcome
Number of treatment emergent adverse events
Time frame: Day 1-112
3 secondary outcomes
Area under the NNC9204-0530 serum concentration-time curve
Time frame: Day 84-112
Time to maximum serum concentration of NNC9204-0530
Time frame: Day 84-112
Change in HbA1C
Time frame: Day -1, 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 5 Sep 2018.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 NNC9204-0530 and liraglutide in people with Metabolism and Nutrition Disorder 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 2 inclusion and 9 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 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?
Number of treatment emergent adverse events (time frame: Day 1-112). 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 Sep 2018.