DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07419854

RecruitingPhase 4

Restoring Facial Volume After GLP-1 Weight Loss With Radiesse

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

1

Enrollment

48

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI 24-32

Primary endpoints

•Cheek Volume•Jowl Volume•Nasolabial Fold Depth

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07419854
Org study IDRAD-VAR-US004

Timeline

Milestones

Study first posted2026-02-19actual
Last update posted2026-02-19actual
Study start2026-02estimated (month precision)
Primary completion2027-08estimated (month precision)
Study completion2027-09estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age21 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (24)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
18
Weight & body composition
4
Patient-reported / QoL
2

Weight & body composition

4 endpoints
Primary/protocol endpoint

Change in Cheek Volume, as quantified by Quantificare's LifeViz Software

Time frame:Up to 6 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Jowl Volume, as quantified by Quantificare's LifeViz Software

Time frame:Up to 6 months

change from baseline, improvement

Primary/protocol endpoint

Body Mass Index (BMI)

Time frame:Up to 12 months

descriptive, improvement

Secondary/protocol endpoint

Change in Cheek Volume, as quantified by Quantificare's LifeViz Software

Time frame:Up to 12 months

change from baseline, improvement

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Psychosocial Questionnaires

Time frame:Up to 12 months

descriptive, improvement

Secondary/protocol endpoint

Patient Treatment Satisfaction

Time frame:Up to 12 months

PGI, change

descriptive, improvement

Other clinical outcomes

18 endpoints
Primary/protocol endpoint

Change in Nasolabial Fold Depth, as quantified by Quantificare's LifeViz Software

Time frame:Up to 6 months

change from baseline, improvement

Primary/protocol endpoint

Change in Marionette Line Depth, as quantified by Quantificare's LifeViz Software

Time frame:Up to 6 months

change from baseline, improvement

Primary/protocol endpoint

Global Aesthetic Improvement Scale (GAIS) for Global Facial Aesthetic Appearance

Time frame:Up to 6 months

categorical status, improvement

Primary/protocol endpoint

Global Aesthetic Improvement Scale (GAIS) for Skin Quality

Time frame:Up to 6 months

categorical status, improvement

Primary/protocol endpoint

Global Aesthetic Improvement Scale (GAIS) for Skin Radiance

Time frame:Up to 6 months

categorical status, improvement

Secondary/protocol endpoint

Changes in Jowl Volume, as quantified by Quantificare's LifeViz Software

Time frame:Up to 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in Nasolabial Fold Depth, as quantified by Quantificare's LifeViz Software

Time frame:Up to 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in Marionette Line Depth, as quantified by Quantificare's LifeViz Software

Time frame:Up to 12 months

change from baseline, improvement

Secondary/protocol endpoint

Merz Cheek Fullness Assessment Scale

Time frame:Up to 12 months

categorical status, descriptive

Secondary/protocol endpoint

Merz Jawline Assessment Scale

Time frame:Up to 12 months

categorical status, improvement

Secondary/protocol endpoint

Merz Aesthetics Nasolabial Fold (At Rest) Scale for Clinical Evaluation

Time frame:Up to 12 months

categorical status, improvement

Secondary/protocol endpoint

Merz Aesthetics Marionette Lines (At Rest) Scale for Clinical Evaluation

Time frame:Up to 12 months

categorical status, improvement

Secondary/protocol endpoint

Merz Aesthetics Oral Commissures (At Rest) Scale for Clinical Evaluation

Time frame:Up to 12 months

categorical status, improvement

Secondary/protocol endpoint

Merz Aesthetics Lower Cheek Fullness (At Rest) Scale for Clinical Evaluation

Time frame:Up to 12 months

categorical status, descriptive

Secondary/protocol endpoint/low confidence

Merz Aesthetics Upper Cheek Fullness (At Rest) Scale for Clinical Evaluation

Time frame:Up to 12 months

categorical status, improvement

Secondary/protocol endpoint

Global Aesthetic Improvement Scale (GAIS) for Global Facial Aesthetic Appearance

Time frame:Up to 12 months

categorical status, improvement

Secondary/protocol endpoint

Global Aesthetic Improvement Scale (GAIS) for Skin Quality

Time frame:Up to 12 months

categorical status, improvement

Secondary/protocol endpoint

Global Aesthetic Improvement Scale (GAIS) for Skin Radiance

Time frame:Up to 12 months

categorical status, improvement

Publications (18)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.