---
title: A Safety and Efficacy Study of HPP404 on Weight Loss in Overweight or Obese Subjects
nct_id: NCT01540864
overall_status: TERMINATED
phase: PHASE2
sponsor: High Point Pharmaceuticals, LLC.
study_type: INTERVENTIONAL
primary_condition: Obesity
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01540864.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01540864"
ct_last_update_post_date: 2015-09-04
last_seen_at: "2026-05-12T07:23:19.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Safety and Efficacy Study of HPP404 on Weight Loss in Overweight or Obese Subjects

**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

**NCT ID:** [NCT01540864](https://clinicaltrials.gov/study/NCT01540864)

## Key Facts

- **Status:** TERMINATED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 126
- **Lead Sponsor:** High Point Pharmaceuticals, LLC.
- **Conditions:** Obesity, Overweight
- **Start Date:** 2012-05
- **Completion Date:** 2013-05
- **CT.gov Last Update:** 2015-09-04

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
```

## Arms

- **HPP404 35 mg** (EXPERIMENTAL)
- **HPP404 50 mg** (EXPERIMENTAL)
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **HPP404** (DRUG) — Administered orally once daily for 26 weeks
- **Placebo** (DRUG) — Administered orally once daily for 26 weeks

## Primary Outcomes

- **Percent weight loss** _(time frame: Day 1 to Day 182)_

## 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)_

## Locations (10)

- Site 11, Augusta, Georgia, United States
- Site 3, Valparaiso, Indiana, United States
- Site 12, Louisville, Kentucky, United States
- Site 9, Hyannis, Massachusetts, United States
- Site 10, Saint Paul, Minnesota, United States
- Site 2, New York, New York, United States
- Site 1, Charlotte, North Carolina, United States
- Site 5, High Point, North Carolina, United States
- Site 7, Norfolk, Virginia, United States
- Site 6, Richmond, Virginia, United States

## Recent Field Changes (last 30 days)

- `eligibility.maxAge` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.site 11|augusta|georgia|united states` — added _(2026-05-12)_
- `locations.site 3|valparaiso|indiana|united states` — added _(2026-05-12)_
- `locations.site 12|louisville|kentucky|united states` — added _(2026-05-12)_
- `locations.site 9|hyannis|massachusetts|united states` — added _(2026-05-12)_
- `locations.site 10|saint paul|minnesota|united states` — added _(2026-05-12)_
- `locations.site 2|new york|new york|united states` — added _(2026-05-12)_
- `locations.site 1|charlotte|north carolina|united states` — added _(2026-05-12)_
- `locations.site 5|high point|north carolina|united states` — added _(2026-05-12)_
- `locations.site 7|norfolk|virginia|united states` — added _(2026-05-12)_
- `locations.site 6|richmond|virginia|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01540864.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01540864*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*