ObesityPhase 2NCT01272765
Anti-psychotic Medication (Stable Dose) Weight Loss Study
A Phase 2 study testing IHBG-10 in people with Obesity, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
Trial summary
This is a pilot study to determine the safety and efficacy of an investigational product (IHBG-10) on weight change and changes in body composition in subjects who have been taking a stable dose of certain anti-psychotic medications for longer than three months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- IHBG-10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jan 2013
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, age 18 and older
- Agree to keep diet, exercise and all current health habits stable during participation in the study
- Currently on a stable dose of Risperdal (Risperidone), Seroquel (Quetiapine) and/or Zyprexa (Olanzapine) for at least three months
Who cannot join
- Current active acute psychotic episode
- Women who are pregnant, breastfeeding, or planning to become pregnant
- Prior bariatric surgery
- Use of prescription or over-the-counter appetite suppressants, herbal products or other medications for weight loss within the past month
- Obesity as a result of a clinically-diagnosed endocrine problem
Trial locations and contacts
1 site in 1 country.
United States1 site
Avera Research Institute
Sioux Falls, South Dakota, 57105
About this study
Official title: Surveillance Study of Weight Response and Body Composition in Subjects Taking a Stable Dose of Risperdal, Seroquel, and/or Zyprexa for Greater Than 3 Months in Combination With 500 mg IHBG-10 TID
This is a pilot study to determine the safety and efficacy of an investigational product (IHBG-10) on weight change and changes in body composition in subjects who have been taking a stable dose of certain anti-psychotic medications for longer than three months.
Read the detailed description
A total of 80 subjects will be enrolled in this study: 20 subjects will be randomized to receive placebo, and 60 will be randomized to receive the investigational product (20 who are on a stable dose of Seroquel, 20 who are on a stable dose of Risperdal, and 20 who are on a stable dose of Zyprexa). The investigational product or placebo will be taken 15 minutes prior to the three main meals of the day. Subjects will continue to take their prescribed anti-psychotic medications. Participation in this study involves four study visits.
- Conditions
- Obesity
- Being tested
- Placebo, IHBG-10
- Keywords
- obesity, weight loss, weight management, anti-psychotic medication, Zyprexa, Seroquel, Risperdal
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Also called sugar pill
Placebo
IHBG-10Dietary supplement
Also called IHBG10
500 mg IHBG-10
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Not described Receives: Other: Placebo |
| Risperdal Group | Experimental | Subjects who are on a stable dose of Ripserdal and taking 500 mg IHBG-10 15 minutes prior to the three main meals of the day. Receives: Dietary Supplement: IHBG-10 |
| Seroquel Group | Experimental | Subjects who are on a stable dose of Seroquel and taking 500 mg of IHBG-10 15 minutes before the three main meals of the day. Receives: Dietary Supplement: IHBG-10 |
| Zyprexa Group | Experimental | Subjects who are on a stable dose of Zyprexa and taking 500 mg of IHBG-10 15 minutes prior to the three main meals of the day. Receives: Dietary Supplement: IHBG-10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: 12 weeks
Secondary outcomes (1)
Body composition
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 posted10 Jan 2011 (estimated)
- Study startMar 2012
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Why it stopped: Study did not get started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avera McKennan Hospital & University Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Zawada, MD, Principal investigator, Avera McKennan Hospital & University Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272765
- Sponsor's protocol ID
- ARI-1320-IHBG10
- Status last verified
- May 2012
- First submitted
- 6 Jan 2011
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance Study of Weight Response and Body Composition in Subjects Taking a Stable Dose of Risperdal, Seroquel, and/or Zyprexa for Greater Than 3 Months in Combination With 500 mg IHBG-10 TID
- ClinicalTrials.gov ID
- NCT01272765
- Acronym / sponsor ID
- ARI-1320-IHBG10
- Conditions
- Obesity
- Keywords
- obesity, weight loss, weight management, anti-psychotic medication, Zyprexa, Seroquel, Risperdal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not get started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Avera McKennan Hospital & University Health CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 10 Jan 2011 (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 is a pilot study to determine the safety and efficacy of an investigational product (IHBG-10) on weight change and changes in body composition in subjects who have been taking a stable dose of certain anti-psychotic medications for longer than three months.
Detailed description
A total of 80 subjects will be enrolled in this study: 20 subjects will be randomized to receive placebo, and 60 will be randomized to receive the investigational product (20 who are on a stable dose of Seroquel, 20 who are on a stable dose of Risperdal, and 20 who are on a stable dose of Zyprexa). The investigational product or placebo will be taken 15 minutes prior to the three main meals of the day. Subjects will continue to take their prescribed anti-psychotic medications. Participation in this study involves four study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Placebo |
| Risperdal Group | Experimental | Dietary Supplement: IHBG-10Subjects who are on a stable dose of Ripserdal and taking 500 mg IHBG-10 15 minutes prior to the three main meals of the day. |
| Seroquel Group | Experimental | Dietary Supplement: IHBG-10Subjects who are on a stable dose of Seroquel and taking 500 mg of IHBG-10 15 minutes before the three main meals of the day. |
| Zyprexa Group | Experimental | Dietary Supplement: IHBG-10Subjects who are on a stable dose of Zyprexa and taking 500 mg of IHBG-10 15 minutes prior to the three main meals of the day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women, age 18 and older
- Agree to keep diet, exercise and all current health habits stable during participation in the study
- Currently on a stable dose of Risperdal (Risperidone), Seroquel (Quetiapine) and/or Zyprexa (Olanzapine) for at least three months
Key exclusion criteria (5 listed)
- Current active acute psychotic episode
- Women who are pregnant, breastfeeding, or planning to become pregnant
- Prior bariatric surgery
- Use of prescription or over-the-counter appetite suppressants, herbal products or other medications for weight loss within the past month
- Obesity as a result of a clinically-diagnosed endocrine problem
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 |
|---|---|---|
| PlaceboAlso: sugar pillPlacebo | Other | Control Group |
| IHBG-10Also: IHBG10500 mg IHBG-10 | Dietary supplement | Risperdal Group, Seroquel Group, Zyprexa Group |
Primary outcome
Weight
Time frame: 12 weeks
1 secondary outcome
Body composition
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
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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.
Edward Zawada, MD principal investigator
Avera McKennan Hospital & University Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IHBG-10 in people with Obesity, run by Avera McKennan Hospital & University Health Center 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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 1 Jun 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Weight (time frame: 12 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 1 Jun 2012.