DelfaGLP-1 Atlas

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LIFETRAIN

Not yet recruitingPhase NA

Personalized Pharmaco-Lifestyle Interventions for Severe Mental Illnesses (LIFETRAIN)

Personalised Pharmaco-Lifestyle Interventions for Severe Mental Illnesses Enhanced by Digital Health and Immersive Technologies

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

5

Recruiting sites

—

Enrollment

140

estimated

Study population

Obesity / overweight, Psychiatric (schizophrenia / bipolar / depression)

Key I/E criterion

•BMI ≥27

Primary endpoint

•SF-36 mental

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 IDNCT07586150
Org study IDLIFETRAIN
Secondary IDU1111-1340-3272Universal Trial Number (UTN)

Timeline

Milestones

Study first posted2026-05-14actual
Last update posted2026-05-14actual
Study start2028-10estimated (month precision)
Primary completion2030-07estimated (month precision)
Study completion2030-12estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightPsychiatric (schizophrenia / bipolar / depression)

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Age 18 to 65 years
•Able and willing to provide written informed consent
•Diagnosis of schizophrenia, bipolar disorder, or major depressive disorder according to DSM-5-TR, confirmed by M.I.N.I.
•Female participants of childbearing potential must agree to use an effective method of contraception
•Stable psychopathology defined as BPRS less than or equal to 41, MADRS less than or equal to 34, and YMRS less than or equal to 25, with stable psychopharmacological treatment for at least 2 weeks
•Reduced functioning at screening defined as SF-36 score less than or equal to 40
•If using benzodiazepines, dose less than or equal to 2 mg lorazepam equivalent per day
•Stable somatic condition for at least 4 weeks
•For semaglutide treatment: overweight with BMI at least 27 and less than 30 kg/m² plus at least one weight-related risk condition, or obesity with BMI at least 30 kg/m²
•For optional adaptive neurostimulation: MADRS score at least 19
•Expected ability to comply with study procedures in the investigator's judgment

Exclusion criteria

•Unable to provide informed consent
•Current or past neurological disorder or structural brain pathology that may affect study procedures
•Known intolerance or hypersensitivity to semaglutide
•Pregnancy or lactation
•Serious suicidal risk
•Substance dependence within the last 3 months
•BMI less than 18.5 kg/m²
•eGFR less than 30 mL/min/1.73 m²
•Type 1 diabetes, diabetic ketoacidosis, diabetic retinopathy, or poorly controlled diabetes with recurrent hypoglycemic episodes
•Pancreatitis, history of pancreatitis, or pancreatic cancer
•Multiple endocrine neoplasia type 2 or personal/family history of medullary thyroid cancer
•Pre-existing significant gastrointestinal conditions such as inflammatory bowel disease or gastroparesis
•Need for acute surgery
•Other medical condition that may affect study procedures or participant safety
•For optional adaptive neurostimulation: nonremovable metal in or around the head, known increased intracranial pressure due to infarcts or trauma, professional metal work or prior ocular metal injury, history of rTMS or ECT, or current (es)ketamine treatment

Endpoints (22)

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

Patient-reported / QoL
8
Other clinical outcomes
7
Weight & body composition
5
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1

Weight & body composition

5 endpoints
Secondary/protocol endpoint

Change in body weight

Time frame:Baseline to Month 3 and Month 6

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body mass index (BMI)

Time frame:Baseline to Month 3 and Month 6

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in waist-to-hip ratio

Time frame:Baseline to Month 3 and Month 6

change from baseline, improvement

Secondary/protocol endpoint

Change in lean mass

Time frame:Baseline to Month 3 and Month 6

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change in fat mass

Time frame:Baseline to Month 3 and Month 6

Total fat mass

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Chage in blood pressure

Time frame:Baseline to Month 3 and Month 6

change from baseline, improvement

Patient-reported / QoL

8 endpoints
Primary/protocol endpoint

Change in Short Form 36 Health Survey (SF-36) Mental Component Summary (MCS) score

Time frame:Baseline to Month 3

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

Change in Short Form 36 Health Survey (SF-36) Mental Component Summary score (MCS) at Month 6

Time frame:Baseline to Month 6

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

Change in Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) score

Time frame:Baseline to Month 3 and Month 6

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in Short Form 36 Health Survey (SF-36) total score

Time frame:Baseline to Month 3 and Month 6

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change in UCLA Loneliness Scale score

Time frame:Baseline to Month 3 and Month 6

change from baseline, improvement

Secondary/protocol endpoint

Change in International Physical Activity Questionnaire

Time frame:Baseline to Month 3 and Month 6

change from baseline, improvement

Secondary/protocol endpoint

Change in EQ-5D-3L score

Time frame:Baseline to Month 3 and Month 6

EQ-5D index

change from baseline, improvement

Secondary/protocol endpoint

Change in Pittsburgh Sleep Quality Index (PSQI) scores

Time frame:Baseline to Month 3 and Month 6

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Incidence of adverse events and serious adverse events

Time frame:Baseline through day 240-243

Serious AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Other clinical outcomes

7 endpoints
Secondary/protocol endpoint

Change in MATRICS Consensus Cognitive Battery

Time frame:Baseline to Month 3 and Month 6

change from baseline, improvement

Secondary/protocol endpoint

Change in Insomnia Severity Index (ISI)

Time frame:Baseline to Month 3 and Month 6

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Brief Psychiatric Rating Scale (BPRS) psychotic symptoms

Time frame:Baseline to Month 3 and Month 6

change from baseline, improvement

Secondary/protocol endpoint

Change in Montgomery-Åsberg Depression Rating Scale (MADRS)

Time frame:Baseline to Month 3 and Month 6

change from baseline, improvement

Secondary/protocol endpoint

Change in Young Mania Rating Scale (YMRS)

Time frame:Baseline to Month 3 and Month 6

change from baseline, improvement

Secondary/protocol endpoint

Change in step aerobic test performance

Time frame:Baseline to Month 3 and Month 6

change from baseline, improvement

Secondary/protocol endpoint

Change in grip strength

Time frame:Baseline to Month 3 and Month 6

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.