DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06977438

Not yet recruitingPhase 4

GLP-1 Plus Lifestyle for Overall Wellness: Find Your Way Forward

GLOW (GLP-1 Plus Lifestyle for Overall Wellness)

Asset

Semaglutide

GLP-1 agonist

Listed sites

0

Recruiting sites

—

Enrollment

1,020

estimated

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoint

•BMI, change

Identifiers

Registered as

NCT IDNCT06977438
Org study IDPEDS-2025-33936

Timeline

Milestones

Study first posted2025-05-18actual
Last update posted2026-02-10actual
Study start2027-01-01estimated
Primary completion2031-01-31estimated
Study completion2032-01-31estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age12 Years
Maximum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Aged 12 to < 18 years at screening
•BMI >/= 95th percentile based on age and sex at screening
•Provide release of information for established primary health provider
•Own a device capable of connecting to the virtual platform sessions with video

Exclusion criteria

•Diabetes (type 1 or 2) due to safety concerns about proper surveillance of glycemic control virtually
•HbA1c >/= 6.5%
•Current or recent (< 6 months prior to screening) use of FDA-approved obesity medications
•Previous metabolic/bariatric surgery or metabolic/bariatric surgery planned during the study period
•Hypertriglyceridemia (TG >/= 500 mg/dL)
•Any past or current diagnosis of an eating disorder (i.e. anorexia nervosa, atypical anorexia nervosa, bulimia nervosa)
•Major psychiatric disorder (e.g. schizophrenia, bipolar disorder)
•Unstable clinically-diagnosed depression, defined as requiring psychiatric hospitalization in the last six months)
•History of suicide attempt
•History of suicidal ideation or self-harm within 30 days of screening
•Patient Health Questionnaire (PHQ-9) score >/= 15 at screening
•Current pregnancy, breast feeding, or plans to become pregnant
•Females refusing to use effective contraception
•Diagnosis of monogenic obesity due to mutations in POMC, PCSK1, or LEPR
•Diagnosis of syndromic obesity including, but not limited to, Bardet Biedl or Prader-Willi Syndrome
•History of cholelithiasis without cholecystectomy
•History of pancreatitis
•Personal history of first-degree relative history of medullary thyroid carcinoma and/or multiple endocrine neoplasia type 2
•Known hypersensitivity to GLP1 agonists
•Other participants from the same household who are participating in this trial
•Any disorder, unwillingness, or inability, which in the investigator's opinion might jeopardize the participant's safety or compliance with the protocol

Endpoints (1)

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.

Weight & body composition

1 endpoint
Primary/protocol endpoint

Body Mass Index (BMI) Reduction

Time frame:24 months

BMI, change

change from baseline, improvement

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.