Actively Recruiting

Phase 4
Age: 21Years - 65Years
All Genders
NCT07419854

Restoring Facial Volume After GLP-1 Weight Loss With Radiesse

Led by Kalpna Kay Durairaj, MD, FACS · Updated on 2026-02-19

48

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

Sponsors

K

Kalpna Kay Durairaj, MD, FACS

Lead Sponsor

M

Merz Aesthetics Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to evaluate the potential of Calcium Hydroxylapatite (CaHA) to restore facial volume and improve skin quality in patients with GLP-1 receptor agonist-associated facial volume loss. Participants will: * Schedule first dose of a prescribed GLP-1 receptor agonist drug to coincide with the baseline visit of this study * Be randomly assigned to one of two groups (Group A will receive off-label injections of hyperdiluted CaHA at Month 0. Group B will receive on-label injections of CaHA after serving as a control group through Month 6) * Have clinical photos taken at each office visit to track progress

CONDITIONS

Official Title

Restoring Facial Volume After GLP-1 Weight Loss With Radiesse

Who Can Participate

Age: 21Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 21 to 65 starting GLP-1 therapy (such as semaglutide or tirzepatide) for weight loss or diabetes management with a target weight loss of 20 pounds or more
  • Body mass index (BMI) between 24 and 32
  • Starting GLP-1 therapy with baseline visit at or within 1 to 2 weeks of first injection to represent pre-weight-loss state
  • Noticeable facial subcutaneous fat without extreme lipoatrophy
  • Willing to receive facial filler injections
  • Able to comply with all study visits and procedures up to 12 months
  • Provide written informed consent including consent for facial imaging
Not Eligible

You will not qualify if you...

  • Any prior facial cosmetic procedures that could affect results, including facial filler or fat transfer in past 2 years; thread lifts or energy-based facial treatments in past year; microneedling, botulinum toxin in depressor anguli oris, or chemical peels in past 4 months; history of surgical lifts or liposuction
  • Current use of retinoids
  • Active dermatologic conditions on face such as severe acne or psoriasis, or facial scars interfering with volume assessment
  • Known allergies or hypersensitivity to Calcium Hydroxylapatite or lidocaine
  • History of severe anaphylactic reactions requiring epinephrine
  • Uncontrolled diabetes or major health conditions making participation unsafe, including bleeding disorders, immunosuppression, or uncontrolled psychiatric illness
  • Pregnant or breastfeeding women
  • Women of childbearing potential not agreeing to use effective contraception during study
  • Becoming pregnant or starting new facial cosmetic treatments during study leads to withdrawal
  • Planning bariatric surgery or other significant weight loss interventions besides GLP-1 during study period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

K. Kay Durairaj, MD, A Medical Corp.

Pasadena, California, United States, 91105

Actively Recruiting

Loading map...

Research Team

K

Kalpna K Durairaj, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here