Evaluation of Safety, Efficacy and Thermogenesis-induction of RZL-012 in Overweight and Obese Volunteers

NCT03171415 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RZL-012-P2aUS-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Weight Loss; Overweight and Obesity

Keywords

Obesity; Overweight; Thermogenesis; Fat reduction

Outcome Measures

Primary Outcomes (2)

• Safety: The Incidence of Treatment-related Adverse Events [AEs]

  AEs will be assessed by significant clinical changes in safety parameter (e.g. vital signs, ECG, clinical laboratory evaluations)AEs incidence will be by body system, seriousness, severity and relation to study drug by cohort.

  0-168 days

• Efficacy: A Significant Thermogenesis at the Injected Site.

  Thermogenesis is measured by thermal imaging is non-invasive, non-radiating Infra-Red thermal camera that passively measures the emitting infra-red radiation of body surface. Difference in temperatures between the sites (treated - not treated) by visit treatment along with the change from baseline (net-delta) in these differences by cohort and overall. Significant thermogenesis is defined as net-delta ≥ 1. Outcome measure data table represents the number of subjects who demonstrated an increase that is higher than 1 celsius degree.

  28-168 days

Secondary Outcomes (10)

• Duration of the Thermogenic Effect From Day 28.

  28-168 days

• Local Reduction in Fat Mass as Measured by MRI. Local Reduction in Fat Will be Measured by Periodically MRI Scans of the Abdomen.

  28-168 days

• Changes in Fasting Blood Glucose From Baseline.

  56 days

• Changes in Blood Lipid Profile From Baseline.

  56 days

• Pharmacokinetics: Establishing Pharmacokinetic Profile of RZL-012.

  1-2 days

Study Arms (2)

RZL-012

EXPERIMENTAL

A single-time injection, multiple subcutaneous injections of RZL-012 administered into 8-36 sites (0.1mL per site): 1. 40mg RZL-012 -administered at 8 sites 2. 80mg RZL-012 - administered at 16 sites 3. 120mg RZL-012 - administered at 24 sites 4. 180mg RZL-012 - administered at 36 sited

Drug: RZL-012

Placebo

PLACEBO COMPARATOR

A single-time injection, multiple subcutaneous injections of Placebo administered into 8-36 sites (0.1mL per site)

Drug: Placebo

Interventions

RZL-012 DRUG

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.

RZL-012

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult male subjects, 20-60 years old.
• Subject is considered overweight and obese, with 27.5 \< BMI ≤ 34.9.
• Significant subcutaneous abdominal fat as defined by Waist to hip ratio (WHR) ≥ 0.9.
• Subjects with stable weight in the last 3 months by medical history.
• Not one of the following eating disorders by subject's declaration: anorexia nervosa, bulimia nervosa.
• Generally considered healthy according to medical history, physical examination, electrocardiogram (ECG) and laboratory evaluation with a special emphasis on metabolic parameters (fasting glucose concentration \< 100 mg, normal blood pressure).
• Subject is willing to refrain from sexual activity or agrees to use a double-barrier contraceptive device (e.g., condom and spermicide) for 4 weeks after treatment with RZL 012.
• Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
• Subjects must sign an informed consent indicating that they are aware of the investigational nature of the study.

You may not qualify if:

• Subjects weighing less than 75 kg.
• Subjects who have reduced/gained weight more than 5% of their current body weight in the last 3 months.
• Unable to tolerate subcutaneous injection.
• Subjects with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorders, that in the opinion of the investigator put the subject at significant risk, are not eligible.
• Subjects who test positive to either Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV) are not eligible.
• Subjects with a clinical history of primary or secondary immunodeficiency, autoimmune disease or subjects taking immunosuppressive drugs such as corticosteroids are ineligible.
• As a result of medical review, physical examination, the PI (or medically qualified nominee) considers the subject unfit for the study.
• Medication use on regular basis.
• Positive drug and alcohol tests.
• Known sensitivity to components of the injection formulation.
• Prior wound, tattoo or infection in the treated area.
• Excessive growth of hair in the abdomen region.
• Claustrophobia or MRI incompatible device or implant.

Sponsors & Collaborators

• Raziel Therapeutics Ltd.: lead
• Spaulding Clinical Research LLC: collaborator

Study Sites (1)

Spaulding Clinical

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss; Overweight

Interventions

RZL-012

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Results Point of Contact

• Title: Racheli Gueta - Clinical Trials Manager
• Organization: Raziel Therapeutics

racheli@raziel-therapy.com

972-8-9126941

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double Blind, Randomized, Placebo Controlled
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a consecutive 4 cohort, dose escalation placebo-controlled clinical trial

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 31, 2017
• Study Start: July 25, 2017
• Primary Completion: December 28, 2018
• Study Completion: December 28, 2018
• Last Updated: August 21, 2019
• Results First Posted: August 21, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)