A Safety and Efficacy Study of HPP404 on Weight Loss in Overweight or Obese Subjects

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01540864

Enrollment

126

Registered

2012-02-29

Start date

2012-05-31

Completion date

2013-05-31

Last updated

2015-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Obesity, Overweight, Body Mass Index

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.

Interventions

DRUGHPP404

Administered orally once daily for 26 weeks

DRUGPlacebo

Administered orally once daily for 26 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percent weight loss	Day 1 to Day 182

Secondary

Measure	Time frame
Number of subjects attaining a 5% or more weight loss	Day 1 to Day 182
Absolute and percent change in Body Mass Index (BMI)	Day 1 to Day 182

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026