ObesityPhase 2NCT01540864
A Safety and Efficacy Study of HPP404 on Weight Loss in Overweight or Obese Subjects
A Phase 2 study testing HPP404 in people with Obesity and Overweight, run by High Point Pharmaceuticals, LLC. at 10 sites in United States.
Trial summary
The purpose of this study is to compare the safety and effect of HPP404 versus placebo on body weight in overweight or obese subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- HPP404
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 10 sitesUnited States
- Study dates
- May 2012to May 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) from 30.0 to 39.9 kg/m2, for subjects with no additional co morbidities;
- BMI from 27 to 39.9 kg/m2, for subjects with co morbidities (i.e. dyslipidemia defined as high LDL (≥ 160 mg/dL) or high total cholesterol (≥ 240 mg/dL), or subjects with hypertension)
Who cannot join
- Systolic blood pressure > 160 mmHg and/or diastolic pressure > 90 mmHg at the Screening Visit without treatment
- History of use of tobacco or nicotine-containing products 180 days prior to Screening visit
- Subjects with type 2 diabetes or fasting blood glucose concentration ≥ 126 mg/dL
- History of appetite or weight modifying surgeries/procedures
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Site 11
Augusta, Georgia, 30909
Site 1
Charlotte, North Carolina, 28277
Site 5
High Point, North Carolina, 27265
Site 9
Hyannis, Massachusetts, 02601
Site 12
Louisville, Kentucky, 40213
Site 2
New York, New York, 10065
Site 7
Norfolk, Virginia, 23502
Site 6
Richmond, Virginia, 23294
Site 10
Saint Paul, Minnesota, 55114
Site 3
Valparaiso, Indiana, 46383
About this study
Official title: A 26 Week Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety and Efficacy of Various Doses of HPP404 on Weight Loss in Overweight or Obese Subjects
The purpose of this study is to compare the safety and effect of HPP404 versus placebo on body weight in overweight or obese subjects.
- Conditions
- Obesity, Overweight
- Being tested
- HPP404, Placebo
- Keywords
- Obesity, Overweight, Body Mass Index
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPP404Drug
Administered orally once daily for 26 weeks
PlaceboDrug
Administered orally once daily for 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| HPP404 35 mg | Experimental | Not described Receives: Drug: HPP404 |
| HPP404 50 mg | Experimental | Not described Receives: Drug: HPP404 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent weight loss
Measured: Day 1 to Day 182
Secondary outcomes (2)
Number of subjects attaining a 5% or more weight loss
Measured: Day 1 to Day 182
Absolute and percent change in Body Mass Index (BMI)
Measured: Day 1 to Day 182
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- High Point Pharmaceuticals, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enrikas Vainorius, M.D., Study director, High Point Pharmaceuticals, LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540864
- Sponsor's protocol ID
- HPP404-201
- Status last verified
- Aug 2015
- First submitted
- 23 Feb 2012
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kokkorakis M, Chakhtoura M, Rhayem C, Al Rifai J, Ghezzawi M, Valenzuela-Vallejo L, Mantzoros CS. Emerging pharmacotherapies for obesity: A systematic review. Pharmacol Rev. 2025 Jan;77(1):100002. doi: 10.1124/pharmrev.123.001045. Epub 2024 Nov 22.
PubMed 39952695
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 26 Week Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety and Efficacy of Various Doses of HPP404 on Weight Loss in Overweight or Obese Subjects
- ClinicalTrials.gov ID
- NCT01540864
- Acronym / sponsor ID
- HPP404-201
- Conditions
- Obesity, Overweight
- Keywords
- Obesity, Overweight, Body Mass Index
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 126 participants (actual)
- Lead sponsor
- High Point Pharmaceuticals, LLC.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 29 Feb 2012 (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.
The purpose of this study is to compare the safety and effect of HPP404 versus placebo on body weight in overweight or obese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HPP404 35 mg | Experimental | Drug: HPP404 |
| HPP404 50 mg | Experimental | Drug: HPP404 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI) from 30.0 to 39.9 kg/m2, for subjects with no additional co morbidities;
- BMI from 27 to 39.9 kg/m2, for subjects with co morbidities (i.e. dyslipidemia defined as high LDL (≥ 160 mg/dL) or high total cholesterol (≥ 240 mg/dL), or subjects with hypertension)
Key exclusion criteria (4 listed)
- Systolic blood pressure > 160 mmHg and/or diastolic pressure > 90 mmHg at the Screening Visit without treatment
- History of use of tobacco or nicotine-containing products 180 days prior to Screening visit
- Subjects with type 2 diabetes or fasting blood glucose concentration ≥ 126 mg/dL
- History of appetite or weight modifying surgeries/procedures
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 |
|---|---|---|
| HPP404Administered orally once daily for 26 weeks | Drug | HPP404 35 mg, HPP404 50 mg |
| PlaceboAdministered orally once daily for 26 weeks | Drug | Placebo |
Primary outcome
Percent weight loss
Time frame: Day 1 to Day 182
2 secondary outcomes
Number of subjects attaining a 5% or more weight loss
Time frame: Day 1 to Day 182
Absolute and percent change in Body Mass Index (BMI)
Time frame: Day 1 to Day 182
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
- Derived from this study: PubMed 39952695Kokkorakis M, Chakhtoura M, Rhayem C, Al Rifai J, Ghezzawi M, Valenzuela-Vallejo L, Mantzoros CS. Emerging pharmacotherapies for obesity: A systematic review. Pharmacol Rev. 2025 Jan;77(1):100002. doi: 10.1124/pharmrev.123.001045. Epub 2024 Nov 22.
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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.
Enrikas Vainorius, M.D. study director
High Point Pharmaceuticals, LLC.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HPP404 in people with Obesity and Overweight, run by High Point Pharmaceuticals, LLC. at 10 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 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: stopped early, as of the sponsor's last update on 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. 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 stopped early. 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?
Percent weight loss (time frame: Day 1 to Day 182). 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 NCT01540864, 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 4 Sep 2015.