Using Radiesse (calcium hydroxylapatite) to restore facial fullness after GLP‑1 weight loss

Restoring Facial Volume After GLP-1 Weight Loss With Radiesse

This will try diluted and standard Radiesse injections to restore facial volume in adults starting GLP‑1 medications for weight loss.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: K. Kay Durairaj, MD, FACS, A Medical Corporation (other)
• Locations: 1 site (Pasadena, California)
• Trial ID: NCT07419854 on ClinicalTrials.gov

What this trial studies

Forty‑eight adults beginning GLP‑1 therapy will be randomly assigned to two groups to compare hyperdiluted calcium hydroxylapatite given at Months 0 and 1 versus on‑label calcium hydroxylapatite given after a 6‑month control period with crossover. Group A receives off‑label hyperdilute CaHA to cheek and prejowl areas early, while Group B serves as control through Month 6 then receives on‑label CaHA to the jawline and folds at Months 6 and 7. Participants will have standardized 3D and AI‑assisted facial imaging, clinical photos, and weight/BMI tracking across scheduled visits over 12 months. The study uses randomization, objective imaging endpoints, and frequent in‑person assessments to measure facial volume and skin quality changes associated with the interventions.

Who should consider this trial

Good fit: Adults 21–65 who are just starting GLP‑1 therapy for weight management, have a BMI in the 24–32 range with expected weight loss of about 20 pounds or more, noticeable facial subcutaneous fat, and willingness to receive facial filler injections and attend follow‑up visits are ideal candidates.

Not a fit: Patients with prior facial cosmetic procedures that would confound results, severe pre‑existing lipoatrophy, those outside the BMI or GLP‑1 timing criteria, or those unwilling/unable to attend the required in‑person visits are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the injections could help people regain facial fullness and improve skin quality after GLP‑1–associated fat loss.

How similar studies have performed: Calcium hydroxylapatite is an established filler for restoring facial volume, but using hyperdiluted CaHA specifically to counteract GLP‑1–associated facial volume loss is relatively novel with limited prior data.

Eligibility criteria

Inclusion Criteria:

* Adults aged 21-65 who are initiating GLP-1 therapy (semaglutide, tirzepatide, or similar) for weight loss or diabetes-related weight management with targeted weight loss of 20 pounds or more
* Participants must have a body mass index (BMI) meeting indications for GLP-1 therapy and within the range of 24-32
* Participants should be at the start of GLP-1 therapy (baseline visit scheduled at or within 1-2 weeks of first GLP-1 injection) so that baseline facial measurements represent their pre-weight-loss state
* Participants must have noticeable facial subcutaneous fat (no pre-existing extreme lipoatrophy) and be willing to receive facial filler injections
* Participants should be able to comply with all study visits and procedures up to 12 months
* Participants must provide written informed consent, including consent for facial imaging

Exclusion Criteria:

* Participants with any prior facial cosmetic procedures that could confound results e.g. facial filler or fat transfer in the past 2 years; thread lifts or energy based device facial treatments in the last 1 year; microneedling, botulinum toxin treatment in the depressor anguli oris (DAO), or chemical peels in the last 4 months; or a history of surgical lifts and/or liposuction
* Participants currently using a retinoid
* Participants with active dermatologic conditions affecting the face (e.g. severe acne, psoriasis on face) or scars that would interfere with volume assessment
* Participants with known allergies or hypersensitivity to CaHA or lidocaine (lidocaine allergy)
* Those with a history of severe anaphylactic reactions requiring epinephrine (due to risk with injectables)
* Those with uncontrolled diabetes or major comorbid conditions that would make participation unsafe (e.g. bleeding disorders that contraindicate injections, immunosuppression that raises infection risk, uncontrolled psychiatric illness such as body dysmorphic disorder)
* Pregnant or breastfeeding women are excluded (GLP-1 therapies are contraindicated in pregnancy, and elective filler is avoided in pregnancy)
* Women of childbearing potential must agree to use an effective contraceptive method during the study (though pregnancy during the short study window is unlikely, this is a precaution)
* If a Participant becomes pregnant or initiates any new facial cosmetic treatment during the Study, they will be withdrawn
* Participants planning bariatric surgery or other significant weight loss interventions (besides the GLP-1 medication) in the study period

Where this trial is running

Pasadena, California

• K. Kay Durairaj, MD, A Medical Corp. — Pasadena, California, United States (RECRUITING)

Study contacts

• Principal investigator: Kalpna K Durairaj, MD — K. Kay Durairaj, MD, A Medical Corp.
• Study coordinator: Kalpna K Durairaj, MD

Conditions: Volume Loss, Calcium Hydroxylapatite, Hyperdiluted Calcium Hydroxylapatite, Minimally invasive, GLP-1 Receptor Agonist, GLP-1, Volume loss