A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 2)

Conditions

• Subcutaneous Fat

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Accepted

Interventions

• CBL-514 Injection — DRUG
  Formulated as an injectable CBL-514 solution at a concentration of 5 mg/mL.
• Placebo — OTHER
  Sodium Chloride (0.9% NaCl) placebo for injection

Study Details

The Stage 2 of this phase 2 study will be a randomized, single-blind, placebo-controlled, parallel, and multiple-dose study to assess the efficacy, safety, and subject satisfaction of CBL-514.

Key Dates

Start date

Feb 14, 2022

Status verified

Apr 2023

Primary completion

Feb 22, 2023

Completion

Mar 22, 2023

Study Design

Enrollment

75 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CBL-514 Injection
  Participant will receive CBL-514 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 4 weeks for up to a maximum of 4 treatments.
• Placebo Comparator: Placebo: 0.9% Sodium Chloride
  Participant will receive 0.9% Sodium Chloride administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 4 weeks for up to a maximum of 4 treatments.

Primary Outcome Measure

Proportion of subjects who lose at least 150 mL of subcutaneous fat compared with placebo [ Time Frame: From Visit 2 (Baseline) up to 8 weeks after last treatment ]

Locations (4)

Find similar trials in Chicago, IL

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