ObesityPhase 3NCT01681069
Efficacy and Safety of IQP-VV-102 in Weight Management
A Phase 3 study testing IQP-VV-102 in people with Obesity and Overweight, run by InQpharm Group at 1 site in Germany.
Trial summary
Subjects are randomized to either IQP-VV-102 or a matching placebo. Over 12 weeks, the subjects' body weight, body fat and safety parameters are monitored Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- IQP-VV-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Jun 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 60 years
- 25 kg/m2 ≤ BMI ≤ 35 kg/m2
- Written informed consent
Who cannot join
- Known sensitivity to sources of the active ingredients and excipients
- Pregnancy or nursing
- Inability to comply with study requirements, e.g. due to language difficulties
- Participation in another study during the last 30 days of the screening visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate the Safety and Efficacy of IQP-VV-102 in Reducing Body Weight in Overweight and Obese Subjects
Subjects are randomized to either IQP-VV-102 or a matching placebo. Over 12 weeks, the subjects' body weight, body fat and safety parameters are monitored
- Conditions
- Obesity, Overweight
- Being tested
- IQP-VV-102, Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQP-VV-102Dietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| IQP-VV-102 | Active comparator | 2 tablets twice a day Receives: Dietary Supplement: IQP-VV-102 |
| Placebo | Placebo comparator | 2 tablets twice a day Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight at End of Study Compared to Baseline
Change in body weight at the end of study compared to baseline
Measured: 12 weeks
Secondary outcomes (2)
Change in Waist Circumference (in cm) at End of Study From Baseline
Difference in waist circumference (in cm) at end of study from baseline
Measured: 12 weeks
Change in Mean Body Fat at End of Study From Baseline
Measured in kg using calibrated weighing scales
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Grube, MD, Principal investigator, Practice for General Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681069
- Sponsor's protocol ID
- INQ/009712
- Status last verified
- Oct 2015
- First submitted
- 4 Sep 2012
- Last updated
- 6 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Grube B, Bongartz U, Alt F. IQP-VV-102, a Novel Proprietary Composition for Weight Reduction: A Double-Blind Randomized Clinical Trial for Evaluation of Efficacy and Safety. Evid Based Complement Alternat Med. 2015;2015:413075. doi: 10.1155/2015/413075. Epub 2015 May 17.
PubMed 26074990
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate the Safety and Efficacy of IQP-VV-102 in Reducing Body Weight in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT01681069
- Acronym / sponsor ID
- INQ/009712
- Conditions
- Obesity, Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Posted 6 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects are randomized to either IQP-VV-102 or a matching placebo. Over 12 weeks, the subjects' body weight, body fat and safety parameters are monitored
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IQP-VV-102 | Active comparator | Dietary Supplement: IQP-VV-1022 tablets twice a day |
| Placebo | Placebo comparator | Other: Placebo2 tablets twice a day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 to 60 years
- 25 kg/m2 ≤ BMI ≤ 35 kg/m2
- Written informed consent
Key exclusion criteria (4 listed)
- Known sensitivity to sources of the active ingredients and excipients
- Pregnancy or nursing
- Inability to comply with study requirements, e.g. due to language difficulties
- Participation in another study during the last 30 days of the screening visit
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 |
|---|---|---|
| IQP-VV-102 | Dietary supplement | IQP-VV-102 |
| Placebo | Other | Placebo |
Primary outcome
Change in Body Weight at End of Study Compared to Baseline
Time frame: 12 weeks
Change in body weight at the end of study compared to baseline
2 secondary outcomes
Change in Waist Circumference (in cm) at End of Study From Baseline
Time frame: 12 weeks
Change in Mean Body Fat at End of Study From Baseline
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26074990Grube B, Bongartz U, Alt F. IQP-VV-102, a Novel Proprietary Composition for Weight Reduction: A Double-Blind Randomized Clinical Trial for Evaluation of Efficacy and Safety. Evid Based Complement Alternat Med. 2015;2015:413075. doi: 10.1155/2015/413075. Epub 2015 May 17.
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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.
Barbara Grube, MD principal investigator
Practice for General Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IQP-VV-102 in people with Obesity and Overweight, run by InQpharm Group at 1 site in Germany.
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 3 inclusion and 4 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 6 Nov 2015. 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Body Weight at End of Study Compared to Baseline (time frame: 12 weeks). 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 NCT01681069, 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 6 Nov 2015.