CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
RZL-012 +1 moredrug
Likely dose
RZL-012 at 8–36 injection sites (0.1 mL per site) into abdominal subcutaneous fat, single administrationAI-extracted
Key inclusion· 7
  • Adult male, age 20–60 years
  • Overweight and obese with BMI 27.5 < BMI ≤ 34.9
  • Significant abdominal subcutaneous fat (waist-to-hip ratio ≥ 0.9)
  • Weight stable over last 3 months
Key exclusion· 11
  • Weight change >5% of current body weight in last 3 months
  • Unable to tolerate subcutaneous injection
  • Uncontrolled cardiac, hepatic, renal, or neurologic/psychiatric disorders
  • Positive for HBV, HCV, or HIV

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03171415
NCT03171415Phase 2Completed

A Double Blind, Randomized, Placebo Controlled, Dose Escalation Phase 2a Clinical Trial for the Evaluation of Safety, Efficacy and Thermogenesis-induction of RZL-012 in Overweight and Obese Volunteers

Raziel Therapeutics Ltd.·interventional·Posted May 31, 2017·Updated Aug 21, 2019

In Brief

A Phase 2 clinical trial evaluating RZL-012 and Placebo for Obesity and 2 related conditions. Completed, enrolled 32 participants across 1 site.

Detailed Summary

Obesity is a direct result of food-intake in excess of body energy expenditure. Thus, induction of increased energy expenditure via the activation of thermogenesis at targeted anatomical sites can counterbalance obesity. This trial aims to study RZL-012, a novel compound, in treating obesity by activating thermogenesis in subcutaneous fat.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 31, 2017
Enrollment StartJul 25, 2017
Primary CompletionDec 28, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.1 years ago

Interventions

RZL-012drug

Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 8-36 sites (0.1mL per site) into the abdominal subcutaneous fat.

Placebodrug

Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8-36 sites (0.1mL per site) into the abdominal subcutaneous fat.