Metabolism and Nutrition DisorderPhase 1NCT00665665
Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Male and Female Volunteers
A Phase 1 study testing NNC 0070-0002-0182 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 will be conducted in the United States of America (USA). The aim of the trial is to investigate whether the drug is safe, well tolerated and to investigate the efficacy of NNC 0070-0002-0182 for the treatment of obesity. The subjects will be treated with drug and placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism and Nutrition Disorder, Obesity
- What is being tested?
- NNC 0070-0002-0182
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2007to Oct 2008
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 30.0-39.0 kg/m2 (obese)
- Females who consent to using double barrier method of contraception, are post-menopausal and older than 50 years, or have had total hysterectomy
Who cannot join
- Clinically significant diseases
- Blood pressure greater than 140/90 mmHg
- Evidence of depression
- Recent diet attempts, treatment with diet drugs (within 3 months)
- Liposuction or other surgery for weight loss within the last year
- Evidence of eating disorders (bulimia, binge eating)
Show all 9Show fewer
- Restricted diets (Kosher, vegetarian)
- Smoker or history of drug or alcohol abuse
- Females of childbearing potential: positive pregnancy test
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Novo Nordisk Investigational Site
Evansville, Indiana, 47710
Novo Nordisk Investigational Site
Madison, Wisconsin, 53704
About this study
Official title: Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Healthy Male and Female Volunteers
This trial will be conducted in the United States of America (USA). The aim of the trial is to investigate whether the drug is safe, well tolerated and to investigate the efficacy of NNC 0070-0002-0182 for the treatment of obesity. The subjects will be treated with drug and placebo. This registration covers the phase 2 part of a combined phase 1/phase 2 trial (phase 1 part of trial conducted between November 2007 and April 2008).
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Being tested
- NNC 0070-0002-0182, 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 0070-0002-0182Drug
4mg initial dose (12 subjects active; 3 subjects placebo); 2mg weekly maintenance dose; for s.c. injection 20mg/vial
placeboDrug
Placebo for s.c. injection
NNC 0070-0002-0182Drug
12mg initial dose (12 subjects active; 3 subjects placebo); 6mg weekly maintenance dose; for s.c. injection 20mg/vial
NNC 0070-0002-0182Drug
32mg initial dose (12 subjects active; 3 subjects placebo); 16mg weekly maintenance dose; for s.c. injection 20mg/vial
NNC 0070-0002-0182Drug
60mg initial dose (12 subjects active; 3 subjects placebo); 30mg weekly maintenance dose; for s.c. injection 20mg/vial
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: NNC 0070-0002-0182; Drug: placebo |
| B | Experimental | Not described Receives: Drug: placebo; Drug: NNC 0070-0002-0182 |
| C | Experimental | Not described Receives: Drug: placebo; Drug: NNC 0070-0002-0182 |
| D | Experimental | Not described Receives: Drug: placebo; Drug: NNC 0070-0002-0182 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses
Measured: after 6 weeks
Secondary outcomes (9)
Pharmacokinetics of NNC 0070-0002-0182 and its isomer
Measured: at 8 weeks
Assessment of changes in food consumption and hunger
Measured: at 6 weeks
Change in weight, waist and hip measurements and mood
Measured: at 6 weeks
Change in body composition and resting metabolism
Measured: at 6 weeks
Intervention arm D only: Change in insulin sensitivity (HOMA)
Measured: at 6 weeks
Intervention arm D only: Change from baseline in body fat (DEXA)
Measured: at 6 weeks
Intervention arm D only: Change from baseline in indirect calorimetry
Measured: at 6 weeks
Intervention arm D only: Change from baseline in adiponectin, hsCRP
Measured: at 6 weeks
Intervention arm D only: Antibody assessment
Measured: at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startNov 2007
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: The trial is terminated due to re-evaluation of the compound
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
- 101 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
- NCT00665665
- Sponsor's protocol ID
- NN9112-1846
- Status last verified
- Dec 2016
- First submitted
- 23 Apr 2008
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT00665665
- Acronym / sponsor ID
- NN9112-1846
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial is terminated due to re-evaluation of the compound
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 24 Apr 2008 (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 will be conducted in the United States of America (USA). The aim of the trial is to investigate whether the drug is safe, well tolerated and to investigate the efficacy of NNC 0070-0002-0182 for the treatment of obesity. The subjects will be treated with drug and placebo. This registration covers the phase 2 part of a combined phase 1/phase 2 trial (phase 1 part of trial conducted between November 2007 and April 2008).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: NNC 0070-0002-0182, Drug: placebo |
| B | Experimental | Drug: placebo, Drug: NNC 0070-0002-0182 |
| C | Experimental | Drug: placebo, Drug: NNC 0070-0002-0182 |
| D | Experimental | Drug: placebo, Drug: NNC 0070-0002-0182 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) between 30.0-39.0 kg/m2 (obese)
- Females who consent to using double barrier method of contraception, are post-menopausal and older than 50 years, or have had total hysterectomy
Key exclusion criteria (9 listed)
- Clinically significant diseases
- Blood pressure greater than 140/90 mmHg
- Evidence of depression
- Recent diet attempts, treatment with diet drugs (within 3 months)
- Liposuction or other surgery for weight loss within the last year
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 0070-0002-01824mg initial dose (12 subjects active; 3 subjects placebo); 2mg weekly maintenance dose; for s.c. injection 20mg/vial | Drug | A |
| placeboPlacebo for s.c. injection | Drug | A, B, C, D |
| NNC 0070-0002-018212mg initial dose (12 subjects active; 3 subjects placebo); 6mg weekly maintenance dose; for s.c. injection 20mg/vial | Drug | B |
| NNC 0070-0002-018232mg initial dose (12 subjects active; 3 subjects placebo); 16mg weekly maintenance dose; for s.c. injection 20mg/vial | Drug | C |
| NNC 0070-0002-018260mg initial dose (12 subjects active; 3 subjects placebo); 30mg weekly maintenance dose; for s.c. injection 20mg/vial | Drug | D |
Primary outcome
To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses
Time frame: after 6 weeks
9 secondary outcomes
Pharmacokinetics of NNC 0070-0002-0182 and its isomer
Time frame: at 8 weeks
Assessment of changes in food consumption and hunger
Time frame: at 6 weeks
Change in weight, waist and hip measurements and mood
Time frame: at 6 weeks
Change in body composition and resting metabolism
Time frame: at 6 weeks
Intervention arm D only: Change in insulin sensitivity (HOMA)
Time frame: at 6 weeks
Intervention arm D only: Change from baseline in body fat (DEXA)
Time frame: at 6 weeks
Intervention arm D only: Change from baseline in indirect calorimetry
Time frame: at 6 weeks
Intervention arm D only: Change from baseline in adiponectin, hsCRP
Time frame: at 6 weeks
Intervention arm D only: Antibody assessment
Time frame: at 10 weeks
Results and safety
The study was stopped early (reason given: The trial is terminated due to re-evaluation of the compound). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Metabolism and Nutrition Disorder
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
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
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
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
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 NNC 0070-0002-0182 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: stopped early, as of the sponsor's last update on 23 Dec 2016. 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 was stopped early (reason given: The trial is terminated due to re-evaluation of the compound). 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?
To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses (time frame: after 6 weeks). 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 23 Dec 2016.