Metabolism and Nutrition DisorderPhase 1NCT03479892
A Research Study Looking at a New Study Medicine (NNC0194-0499) for Weight Control in People 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 study looks at a new study medicine for weight control in people with overweight or obesity. The aim of this study is to see if the study medicine is safe for people to take. The study also looks at how fast the body removes the study medicine. Read more about this study
- Who is it for?
- Ages 22 to 55 years
- 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
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2018to 4 Jun 2019
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male aged 22-55 years (both inclusive) or female aged 22-45 years (both inclusive) at the time of signing informed consent
- Female must have regular menstrual cycle(defined as 24-35 days between 1st day of menses for two most recent menstrual periods, self-reported)
- Female must have bilateral tubal ligation or must be willing to use non-hormonal intrauterine device or diaphragm /cervical cap with spermicide in combination with condom for male partner(s)
- Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator
- Considered by the investigator to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG, and clinical laboratory tests performed during the screening visit
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 medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening. Mild painkillers are allowed until 24 hours prior to screening
- History or presence of bone disease or otherwise increased risk of bone fracture as evaluated by dual-energy x-ray absorptiometry and as judged by the investigator
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, Multiple-dose, Dose-escalation Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Subjects With Overweight or Obesity
This study looks at a new study medicine for weight control in people with overweight or obesity. The aim of this study is to see if the study medicine is safe for people to take. The study also looks at how fast the body removes the study medicine. The participants will either get NNC0194-0499 (the study medicine) or placebo (a formula that looks like the medicine but does not have active ingredients). Which treatment the participants get is decided by chance. The participants will get 1 or more injections into the skin of stomach area once each week for 12 weeks. The study will last for about 4 to 5 months. The participants will have 18 visits to the clinic.
- 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
Participants will receive NNC0194-0499 (s.c., in a lifted fold of the abdominal skin) injection once weekly at increasing doses of 3.0 mg, 9.0 mg, 27 mg, 60 mg, or 120 mg. Each participant will only be given one dose level.
Dose escalation will proceed to the next planned dose level if there are no safety concerns raised by the investigator or by the trial safety group.
PlaceboDrug
Participants will receive once weekly injections of NNC0194-0499 matched placebo.
| Study group | Role | What they receive |
|---|---|---|
| NNC0194-0499 | Experimental | Participants will receive increasing doses of NNC0194-0499. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks. Receives: Drug: NNC0194-0499 |
| Placebo | Placebo comparator | Participants will receive NNC0194-0499 matched placebo. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks. 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 of events
Measured: From first administration of NNC0194-0499 (Day 1) to follow-up (Day 112)
Secondary outcomes (15)
Change in heart rate
measured in beats per minute
Measured: Baseline (Day 1), Follow-up (Day 112)
Change in biochemistry
Parameters: Calcium (total), Chloride, Magnesium, Phosphate (inorganic), Potassium, Sodium, Urea (blood urea nitrogen, BUN), Uric acid, Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Amylase, Aspartate aminotransferase (AST), Creatinine kinase (CK, total), Gamma glutamyltransferase (GGT), Lactase dehydrogenase, Lipase, Albumin, Bicarbonate, Bilirubin (total), Creatinine, High sensitivity C-reactive protein (hsCRP) and Total protein in SI units
Measured: Baseline (Day -1), Follow-up (Day 112)
Change in haematology
Parameters: Erythrocytes, Reticulocytes, Thrombocytes, Leucocytes (total), Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Haemoglobin, Haematocrit, Mean corpuscular volume (MCV) and Mean corpuscular haemoglobin concentration (MCHC) in SI units
Measured: Baseline (Day -1), Follow-up (Day 112)
Change in fibrinogen
measured in g/L
Measured: Baseline (Day -1), Follow-up (Day 112)
Change in prothrombin time read as international normalised ratio (INR)
Measured: Baseline (Day -1), Follow-up (Day 112)
Change in activated partial thromboplastin time (APTT)
measured in seconds
Measured: Baseline (Day -1), Follow-up (Day 112)
Changes in electrocardiogram (ECG)
Parameters: RR interval, PR interval, QRS interval, QT interval and QTcF interval in SI units
Measured: Baseline (Day 1), Follow-up (Day 112)
Number of injection site reactions
count of injection site reactions
Measured: From baseline (Day 1) to follow-up (Day 112)
Occurrence of anti-NNC0194-0499 antibodies
Measured: From baseline (Day 1) to follow-up (Day 112)
t½,SS: the terminal serum half-life of NNC0194-0499 at steady state
Calculated based on serum concentrations of NNC0194-0499
Measured: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
Cmax,SS: the maximum concentration of NNC0194-0499 in serum at steady state
Calculated based on serum concentrations of NNC0194-0499
Measured: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
tmax,SS: the time to maximum concentration of NNC0194-0499 in serum at steady state
Calculated based on serum concentrations of NNC0194-0499
Measured: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
CL/F SS: the apparent total serum clearance of NNC0194-0499 at steady state
Calculated based on serum concentrations of NNC0194-0499
Measured: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
Change in systolic blood pressure
measured in mmHg
Measured: Baseline (Day 1), Follow-up (Day 112)
Change in diastolic blood pressure
measured in mmHg
Measured: Baseline (Day 1), Follow-up (Day 112)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start13 Mar 2018
- Primary completion4 Jun 2019
- Study completion4 Jun 2019
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
- 57 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
- NCT03479892
- Sponsor's protocol ID
- NN9499-4287
- Other IDs
- U1111-1193-7228
- Status last verified
- Jun 2019
- First submitted
- 9 Mar 2018
- Last updated
- 26 Jun 2019
- 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 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blinded, Multiple-dose, Dose-escalation Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Subjects With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT03479892
- Acronym / sponsor ID
- NN9499-4287
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 27 Mar 2018 (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 study looks at a new study medicine for weight control in people with overweight or obesity. The aim of this study is to see if the study medicine is safe for people to take. The study also looks at how fast the body removes the study medicine. The participants will either get NNC0194-0499 (the study medicine) or placebo (a formula that looks like the medicine but does not have active ingredients). Which treatment the participants get is decided by chance. The participants will get 1 or more injections into the skin of stomach area once each week for 12 weeks. The study will last for about 4 to 5 months. The participants will have 18 visits to the clinic.
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 |
|---|---|---|
| NNC0194-0499 | Experimental | Drug: NNC0194-0499Participants will receive increasing doses of NNC0194-0499. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive NNC0194-0499 matched placebo. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks. |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male aged 22-55 years (both inclusive) or female aged 22-45 years (both inclusive) at the time of signing informed consent
- Female must have regular menstrual cycle(defined as 24-35 days between 1st day of menses for two most recent menstrual periods, self-reported)
- Female must have bilateral tubal ligation or must be willing to use non-hormonal intrauterine device or diaphragm /cervical cap with spermicide in combination with condom for male partner(s)
- Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator
- Considered by the investigator to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG, and clinical laboratory tests performed during the screening visit
Key exclusion criteria (3 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 medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening. Mild painkillers are allowed until 24 hours prior to screening
- History or presence of bone disease or otherwise increased risk of bone fracture as evaluated by dual-energy x-ray absorptiometry and 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 |
|---|---|---|
| NNC0194-0499Participants will receive NNC0194-0499 (s.c., in a lifted fold of the abdominal skin) injection once weekly at increasing doses of 3.0 mg, 9.0 mg, 27 mg, 60 mg, or 120 mg. Each participant will only be given one dose level. Dose escalation will proceed to the next planned dose level if there are no safety concerns raised by the investigator or by the trial safety group. | Drug | NNC0194-0499 |
| PlaceboParticipants will receive once weekly injections of NNC0194-0499 matched placebo. | Drug | Placebo |
Primary outcome
Number of treatment emergent adverse events (TEAEs)
Time frame: From first administration of NNC0194-0499 (Day 1) to follow-up (Day 112)
count of events
15 secondary outcomes
Change in heart rate
Time frame: Baseline (Day 1), Follow-up (Day 112)
Change in biochemistry
Time frame: Baseline (Day -1), Follow-up (Day 112)
Change in haematology
Time frame: Baseline (Day -1), Follow-up (Day 112)
Change in fibrinogen
Time frame: Baseline (Day -1), Follow-up (Day 112)
Change in prothrombin time read as international normalised ratio (INR)
Time frame: Baseline (Day -1), Follow-up (Day 112)
Change in activated partial thromboplastin time (APTT)
Time frame: Baseline (Day -1), Follow-up (Day 112)
Changes in electrocardiogram (ECG)
Time frame: Baseline (Day 1), Follow-up (Day 112)
Number of injection site reactions
Time frame: From baseline (Day 1) to follow-up (Day 112)
Occurrence of anti-NNC0194-0499 antibodies
Time frame: From baseline (Day 1) to follow-up (Day 112)
t½,SS: the terminal serum half-life of NNC0194-0499 at steady state
Time frame: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
Cmax,SS: the maximum concentration of NNC0194-0499 in serum at steady state
Time frame: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
tmax,SS: the time to maximum concentration of NNC0194-0499 in serum at steady state
Time frame: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
CL/F SS: the apparent total serum clearance of NNC0194-0499 at steady state
Time frame: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
Change in systolic blood pressure
Time frame: Baseline (Day 1), Follow-up (Day 112)
Change in diastolic blood pressure
Time frame: Baseline (Day 1), Follow-up (Day 112)
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 Jun 2019.
- 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.
Clinical Reporting Anchor and Disclosure (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 5 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 26 Jun 2019. 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 first administration of NNC0194-0499 (Day 1) to follow-up (Day 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 26 Jun 2019.