GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 4

Tirzepatide in PWS, HO and GNSO

The Effects of Tirzepatide in Young Adults With Prader-Willi Syndrome, Hypothalamic Obesity and General Non-Syndromic Obesity

Lead sponsor

Grace Kim

Assets

GLP-1 / incretin class catch-all / Tirzepatide

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Hypothalamic / syndromic obesity, Obesity / overweight

Key I/E criterion

—

Primary endpoint

•Body weight, % change

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 IDNCT06901245

Org study IDSTUDY00004995

Secondary IDI8F-NS-I001Lilly USA

Timeline

Milestones

Study first posted2025-03-28actual

Study start2025-05-01actual

Last update posted2025-09-16actual

Primary completion2026-06estimated (month precision)

Study completion2026-12estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all Tirzepatide

Study populations

Who this study enrolls

Hypothalamic / syndromic obesityObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age26 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Individuals 18-26 years with a BMI in the obesity range (BMI ≥95th percentile for age and sex or ≥30 kg/m2) with either 1) genetically confirmed diagnosis of PWS, 2) hypothalamic obesity as defined by damage to the medial hypothalamic region resulting in dysregulation of satiety and energy balance as diagnosed by a physician, 3) general obesity unrelated to a genetic syndrome or underlying medical condition

•In a stable care setting at least 6 months prior to enrollment

•Able and willing to participate in study visits including tolerating blood draws, urine samples and tolerate DXA scan.

•Ability to take weekly subcutaneous tirzepatide

•Consistent caregiver if they are not independent

•Stable diet and exercise regimen for at least 6 months prior to enrollment

•Able to use contraceptive methods if able to conceive offspring in order to prevent unintentional pregnancy during the study

Exclusion criteria

•Current or recent (within 3 months of start of study drug initiation) use of weight loss medications

•Current use of insulin or sulfonylurea or other medication affecting insulin secretion or GLP1 clearance

•Current or prior use of any GLP1A or DPP4 inhibitor during the 6 months before screening

•Any medications that may affect the study endpoints

•Significant weight change (>3% weight gain or loss) in the last 2 months prior to enrollment

•Change in dose of chronic endocrine medications (testosterone, estrogen, levothyroxine, or growth hormone medications) >10%/kg/day for at least 3 months prior to study

•Current pregnancy or desire to become pregnant within study period, current lactation

•History of recurrent pancreatitis, CKD, gastroparesis

•Chronic/acute heart, kidney, or liver disease

•Personal or family history of medullary thyroid carcinoma or MEN syndrome type 2

•Uncontrolled diabetes (A1C >8.5%)

•DVT

•Cancer within the previous 5 years

•Current participation in an interventional clinical study

•Previous or planned surgical treatment for obesity

•Individuals with current substance abuse equivalnt to moderate or severe based on DSM 5 criteria (Hasin DS, 2013)

•Any suicidal ideation in the past year

•Unable to perform any of the procedures for the study

•Have a body weight, height, and/or width that that prohibits the ability to obtain accurate measurements according to the DXA manufacturer's specification

•Any condition that would prevent successful participation in the study.

Endpoints (15)

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

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

Patient-reported / QoL

Other clinical outcomes

Weight & body composition

3 endpoints

Primary/protocol endpoint

Change in weight

Time frame:48 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in BMI

Time frame:48 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in fat mass

Time frame:48 weeks

Total fat mass

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Secondary/protocol endpoint

Change in metabolic markers - fasting plasma glucose

Time frame:48 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in metabolic markers- fasting insulin

Time frame:48 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in metabolic markers - hemoglobin A1C

Time frame:48 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in metabolic markers- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

Time frame:48 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Change in metabolic markers - fasting lipids

Time frame:48 weeks

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Change in appetite - CoEQ (Control of Eating Questionnaire)

Time frame:48 weeks

change from baseline, improvement

Safety / tolerability / PK

5 endpoints

Other/protocol endpoint

Change in safety markers -CBC

Time frame:48 weeks

change from baseline, descriptive

Other/protocol endpoint

Change in safety markers - CMP

Time frame:48 weeks

change from baseline, descriptive

Other/protocol endpoint

Change in safety markers - coagulation factor assay PT [prothrombin time]

Time frame:48 weeks

change from baseline, descriptive

Other/protocol endpoint

Change in safety markers - coagulation factor assay- PTT [Activated Partial Thromboplastin Time ]

Time frame:48 weeks

change from baseline, descriptive

Other/protocol endpoint

Change in safety markers - coagulation factor assay - INR [international normalized ratio].

Time frame:48 weeks

change from baseline, descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Change in appetite - Physician Rated Hyperphagia Severity Scale

Time frame:48 weeks

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.