RecruitingPhase NA

Efficacy and Safety of a Drinkable Nutraceutical for Hair Loss in Patients Using GLP-1/GIP Receptor Agonists

Evaluation of the Efficacy and Safety of a Drinkable Nutraceutical in Improving Hair Loss in Patients Treated With GLP-1/GIP Receptor Agonists: a Double-blind, 1:1 Randomized, Placebo-controlled Study.

Lead sponsor

Olistic Research Labs S.L.

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight

Eligibility highlights

•Female

Primary endpoint

•Hair loss

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07484061

Org study IDCT-ON-04

Timeline

Milestones

Study start2026-03-16actual

Study first posted2026-03-19actual

Last update posted2026-03-23actual

Primary completion2026-08-31estimated

Study completion2026-10-31estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age35 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

•Female gender.

•Age >35 years.

•Initiation of treatment with a GLP-1/GIP agonist, or treatment duration < 3 months, as per routine clinical practice in the endocrinology clinic.

•Having signed the participant information sheet and the written informed consent and having been informed of the objective of the study.

•Additional criteria to be included by the client.

Exclusion criteria

•Allergy or hypersensitivity to any of the components of the product, or to a product from a similar category to the one being tested.

•Scalp diseases: cicatricial alopecia, alopecia areata, folliculitis decalvans, psoriasis, moderate to severe seborrheic dermatitis, eczema, cancer, etc.

•Women presenting alopecia due to an underlying medical condition (hypothyroidism, anemia, lupus, etc.).

•Pharmacological treatment that may promote the onset of telogen effluvium, initiated within the 3 months prior to study start (e.g., valproic acid, carbamazepine, phenytoin, selective serotonin reuptake inhibitors, oral anticoagulants, retinoids, beta-blockers). Patients who have undergone a dose change of these medications within the same period are also excluded.

•Women with uncontrolled thyroid disorders (hyperthyroidism or hypothyroidism) within the 6 months prior to study initiation.

•Women who have used anti-hair loss products within the last 3 months.

•Women who have initiated or undergone dermatological treatment for hair loss within the last 6 months (minoxidil, finasteride, PRP, mesotherapy, etc.).

•Women who have undergone hair transplantation within the 18 months prior to study initiation.

•Women who have initiated treatment with anxiolytics, antidepressants, amphetamines, ACE inhibitors, or iron within the last 3 months.

•Women who initiated or discontinued hormonal treatment (oral contraceptives, oral or topical hormone replacement therapy, ovarian stimulation) within the 3 months prior to study initiation.

•Pregnant women, postpartum women (within 6 months), breastfeeding women, or women planning to become pregnant during the study period.

•Additional exclusion criteria to be specified by the sponsor.

•Any condition that, in the investigator's opinion, makes participation in the study inappropriate.

Endpoints (35)

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 (unclassified)

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

MASH / liver

Patient-reported / QoL

Renal / kidney