Metabolism and Nutrition DisorderPhase 1NCT01044108
A Two Part Trial Investigating an Anti-obesity Drug in Overweight/Obese Male and Female Healthy Volunteers
A Phase 1 study testing NNC 0070-0002-0453 and '2-0453 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 investigate the safety, tolerability, efficacy and pharmacokinetics (the rate at which the trial drug is eliminated from the body) of NNC 0070-0002-0453 in overweight/obese, but otherwise healthy male and female volunteers. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism and Nutrition Disorder, Obesity
- What is being tested?
- NNC 0070-0002-0453 and '2-0453
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2010to 20 Sep 2011
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- FOR TRIAL PART 1, THE FOLLOWING APPLIES:
- Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject
- Overweight/obese males: Body Mass Index (BMI) between 27.0 to 39.0 kg/m2
- Good general health
- FOR TRIAL PART 2, THE FOLLOWING APPLIES:
- Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject.
- Obese male and female subjects: Body Mass Index (BMI) between 30.0 to 39.0 kg/m2
- Good general health.
Who cannot join
- Aggressive diet attempts within the last 3 months
- Current or history of treatment with medications that may cause significant weight gain
- History of major depressive disorder or history of a suicide attempt or history of any suicidal behaviour
- History of eating disorders
- Any weight change of 5 kg (11 pounds) in the last 3 months
- Tobacco use
- History of alcoholism or drug/chemical abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
Evansville, Indiana, 47710
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Two Part Trial (Sequential Single Subcutaneous Dose Rising Trial and Semi-Sequential Multiple Subcutaneous Dose Response Trial) to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of NNC 0070-0002-0453 in Overweight/Obese Male and Female Subjects
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability, efficacy and pharmacokinetics (the rate at which the trial drug is eliminated from the body) of NNC 0070-0002-0453 in overweight/obese, but otherwise healthy male and female volunteers. Selected subjects will continue in a follow-up period of up to 5 years.
Read the detailed description
Due to an unfavourable benefit-risk profile observed during the phase 1 trial for the obesity project, NN9161, Novo Nordisk has decided to terminate further clinical development.
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Being tested
- NNC 0070-0002-0453, '2-0453, 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.
NNC 0070-0002-0453Drug
Administration of a single subcutaneous (under the skin) dose. Up to 7 escalating dose levels will be investigated. Progression to next dose level will be based on a safety evaluation.
'2-0453Drug
Administration of multiple subcutaneous (under the skin) doses for 10 weeks. Up to 4 escalating dose levels will be investigated. Progression to next dose level will be based on a safety evaluation.
placeboDrug
Placebo will be administered as a comparator at each dose level.
| Study group | Role | What they receive |
|---|---|---|
| Trial, part 1 (males only) | Experimental | Not described Receives: Drug: NNC 0070-0002-0453; Drug: placebo |
| Trial, part 2 (males and females) | Experimental | Not described Receives: Drug: '2-0453; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of adverse events
Measured: From the first trial related activity (Day 1) and until completion of the post treatment follow-up visit (Day 22 +/- 1)
Secondary outcomes (2)
Terminal half-life (t½)
Measured: After administration of a single dose of trial drug
AUC 0-24h, area under the '2-453 concentration-time curve
Measured: From 0 to 24 hours after steady state
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study start5 Jan 2010
- Primary completion13 Dec 2010
- Study completion20 Sep 2011
Why it stopped: See detailed description
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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 117 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
- NCT01044108
- Sponsor's protocol ID
- NN9161-3749
- Other IDs
- U1111-1112-7351
- Status last verified
- Jul 2017
- First submitted
- 6 Jan 2010
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Two Part Trial (Sequential Single Subcutaneous Dose Rising Trial and Semi-Sequential Multiple Subcutaneous Dose Response Trial) to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of NNC 0070-0002-0453 in Overweight/Obese Male and Female Subjects
- ClinicalTrials.gov ID
- NCT01044108
- Acronym / sponsor ID
- NN9161-3749
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See detailed description
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2010 (actual)
- Primary completion
- 13 Dec 2010 (actual)
- Study completion
- 20 Sep 2011 (actual)
- First posted
- 7 Jan 2010 (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 (USA). The aim of this trial is to investigate the safety, tolerability, efficacy and pharmacokinetics (the rate at which the trial drug is eliminated from the body) of NNC 0070-0002-0453 in overweight/obese, but otherwise healthy male and female volunteers. Selected subjects will continue in a follow-up period of up to 5 years.
Detailed description
Due to an unfavourable benefit-risk profile observed during the phase 1 trial for the obesity project, NN9161, Novo Nordisk has decided to terminate further clinical development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial, part 1 (males only) | Experimental | Drug: NNC 0070-0002-0453, Drug: placebo |
| Trial, part 2 (males and females) | Experimental | Drug: '2-0453, Drug: placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- FOR TRIAL PART 1, THE FOLLOWING APPLIES:
- Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject
- Overweight/obese males: Body Mass Index (BMI) between 27.0 to 39.0 kg/m2
- Good general health
- FOR TRIAL PART 2, THE FOLLOWING APPLIES:
Key exclusion criteria (7 listed)
- Aggressive diet attempts within the last 3 months
- Current or history of treatment with medications that may cause significant weight gain
- History of major depressive disorder or history of a suicide attempt or history of any suicidal behaviour
- History of eating disorders
- Any weight change of 5 kg (11 pounds) in the last 3 months
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 |
|---|---|---|
| NNC 0070-0002-0453Administration of a single subcutaneous (under the skin) dose. Up to 7 escalating dose levels will be investigated. Progression to next dose level will be based on a safety evaluation. | Drug | Trial, part 1 (males only) |
| '2-0453Administration of multiple subcutaneous (under the skin) doses for 10 weeks. Up to 4 escalating dose levels will be investigated. Progression to next dose level will be based on a safety evaluation. | Drug | Trial, part 2 (males and females) |
| placeboPlacebo will be administered as a comparator at each dose level. | Drug | Trial, part 1 (males only), Trial, part 2 (males and females) |
Primary outcome
Number and severity of adverse events
Time frame: From the first trial related activity (Day 1) and until completion of the post treatment follow-up visit (Day 22 +/- 1)
2 secondary outcomes
Terminal half-life (t½)
Time frame: After administration of a single dose of trial drug
AUC 0-24h, area under the '2-453 concentration-time curve
Time frame: From 0 to 24 hours after steady state
Results and safety
The study was stopped early (reason given: See detailed description). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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 NNC 0070-0002-0453 and '2-0453 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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 27 Jul 2017. 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. 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 was stopped early (reason given: See detailed description). Results are not available in the source record.
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 and severity of adverse events (time frame: From the first trial related activity (Day 1) and until completion of the post treatment follow-up visit (Day 22 +/- 1)). 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 27 Jul 2017.