DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07326111

PERIODS

RecruitingPhase 4

A Clincial Study Testing Tirzepatide on Reproductive Function and Metabolic Health in Women With PCOS Who Are Overweight or Obese

A Clinical Trial of Tirzepatide (LY3298176) in Subjects With Overweight or Obesity and PCOS-related Ovarian Dysfunction

Lead sponsor

University of Bonn

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

2

Recruiting sites

1

Enrollment

198

estimated

Study population

Obesity / overweight, PCOS

Key I/E criteria

•BMI ≥27•Female

Primary endpoints

•Menstrual cyclicity•Ovulation rate

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 IDNCT07326111
Org study IDMED1-202202
Secondary ID2024-515982-32-00

Timeline

Milestones

Study start2025-12-09actual
Study first posted2026-01-08actual
Last update posted2026-01-08actual
Primary completion2028-12estimated (month precision)
Study completion2029-12estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightPCOS

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexFemale
Healthy volunteersNot accepted

Eligibility criteria

General Inclusion Criteria

•Written informed consent to participate in this clinical trial in accordance with local regulations and the ethical review board governing this clinical trial
•Subjects
–motivated, capable, and willing to self-inject IMP, as required for this protocol.
–motivated, capable, and willing to follow trial procedures for the duration of the clinical trial, includ-ing, but not limited to lifestyle, dietary and exercise advice.
–motivated, capable, and willing to complete trial diaries and required questionnaires.

Indication-specific Inclusion Criteria

•Females aged 18 - 45 years of childbearing potential
•At least 3 years post-menarche and premenopausal
•BMI ≥ 27 kg/m²
•Previous diagnosis of PCOS, defined by Rotterdam criteria
•Oligomenorrhea or secondary amenorrhea with irregular periods (defined as cycle length less than 21 or more than 35 days or < 8 cycles per year); within the last 10 years (if currently receiving hormonal contraceptive treatment) OR over the last year in the absence of hormonal contraceptive treatment
•Biochemical signs of hyperandrogenism with total testosterone in upper 95th Percentile AND free androgen index (FAI) > ULN and/or clinical signs of hyperandrogenism
•Hormonal contraceptive naïve or not on hormonal contraceptives six months prior to screening, willing to be without hormonal contraceptives for the duration of the clinical trial and to perform safe alternate contraception (barrier methods) during the 72-week IMP intake period and 30 days after the last dose of IMP

General Exclusion Criteria

•Subjects without legal capacity who are unable to understand the nature, scope, significance and consequences of this clinical trial
•Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the trial results, or may interfere with the subject's participation in this clinical trial
–Note: Patients with depression or other psychiatric disorder whose disease state is considered stable and expected to remain stable throughout the course of the clinical trial, in the opinion of the investigator, may be considered for inclusion.
–Note: Subjects with a lifetime suicidal event cannot be considered for inclusion
•Simultaneous participation in another clinical trial, or participation in a clinical trial taking an investiga-tional product, up to 30 days after last IMP intake in that clinical trial
•Known or persistent abuse of medication, drugs or alcohol
•History of an active or untreated malignancy or being in remission from a clinically significant malig-nancy for less than 5 years

o Excluding basal- or squamous-cell skin cancer or in situ carcinomas of the cervix

•Prior diagnosis of severe renal impairment or measured as estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² during screening
•Acute or chronic hepatitis, signs and symptoms of any other liver disease other than non-alcoholic fatty liver disease, or alanine aminotransferase (ALT) level > 3.0 X the upper limit of normal, as deter-mined by the laboratory during screening
•History of gastric emptying abnormality (e.g., gastroparesis, gastric outlet obstruction or chronic de-pendence on drugs that significantly affect gastric emptying)
•Current (positive pregnancy test, e.g., ß-HCG test in urine / serum) or planned pregnancy during the 72-week treatment period from randomization, or nursing women

Indication-specific Exclusion Criteria

•Prior diagnosis of diabetes mellitus other forms than type 2

o Note: Excluding prior history of gestational diabetes

•In case of diabetes mellitus type 2, exclusion of subjects
–on DPP-4 inhibitors, GLP-1R agonist and/or a dual/triple incretin agonist (up to 6 months prior to screening)
–on sulfonylureas or insulin (basal and/or bolus)
–with uncontrolled diabetes (HbA1c > 8.5%)
–with non-proliferative diabetic retinopathy requiring acute treatment
–with diabetic maculopathy
–Note: use of metformin or SGLT-2-inhibitor (if needed for glycemic control in type-2-diabetes) is allowed
•Current or prior treatment (up to 6 months prior to screening) with GLP-1R agonist or a dual incretin agonist for obesity or other indications
•Use of inositol formulations (up to 6 months prior to screening)
•Congenital adrenal hyperplasia (CAH, classic and non-classic forms)
•Thyroid, pituitary, and/or adrenal disease (if not appropriately treated)

o Note: Excluding stable disease and/or stable drug dose 12 weeks before screening

•Hyperprolactinaemia
•Known history of benign intrauterine lesions
•Hysterectomy
•Known history of hypersensitivity against tirzepatide or excipients
•Known history of hypersensitivity against medroxyprogesterone acetate or dydrogesterone or any other ingredients of the Auxiliary Medicinal Products
•Known personal or family history of medullary thyroid cancer or subjects with Multiple Endocrine Ne-oplasia syndrome type 2 (MEN 2)
•Elevated calcitonin levels as determined by the laboratory during screening
–≥ 20 ng/L, if eGFR ≥ 60 mL/min/1.73 m2
–≥ 35 ng/L, if eGFR < 60 mL/min/1.73 m2
•Known secondary cause of obesity (i.e., Cushing syndrome) or monogenetic or syndromic forms of obesity (i.e., melanocortin 4 receptor deficiency or Prader Willi Syndrome)
•Known history of acute or chronic pancreatitis
•Previous or planned bariatric surgery or endoscopic and/or device-based therapy for obesity

o Note: excluding liposuction or abdominoplasty if performed > 1 year prior to screening

•Vaginal bleeding of unknown cause
•Known thromboembolic events or active thrombophlebitis

Endpoints (59)

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
26
Cardiometabolic biomarkers
8
Patient-reported / QoL
8
Weight & body composition
7
Glycemic / diabetes
6
MASH / liver
4

Weight & body composition

7 endpoints
Secondary/protocol endpoint

Percentage Change in Body Weight from Baseline to Week 72

Time frame:Baseline and Week 72

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥ 5%, ≥ 10%, ≥ 15%, and ≥ 20% Body Weight Loss

Time frame:Baseline and Week 72

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Body Composition (BIA) at Week 72

Time frame:Baseline and Week 72

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference and Waist-to-Hip Ratio

Time frame:Baseline and Week 72

Waist circumference, change

change from baseline, improvement

componentsWaist circumference, change, waist to hip ratio change

Other/protocol endpoint

Change From Baseline in Body Weight and Composition at Week 124

Time frame:Baseline and Week 124

change from baseline, improvement

componentsBody weight, absolute change (kg), Total fat mass, Lean mass

Other/protocol endpoint

Percentage of Participants Maintaining Weight Loss Thresholds at Week 124

Time frame:Week 124

threshold achievement, improvement

Other/protocol endpoint

Change From Baseline in Waist Circumference and Waist-to-Hip Ratio at Week 124

Time frame:Baseline and Week 124

Waist circumference, change

change from baseline, improvement

componentsWaist circumference, change, waist to hip ratio change

Glycemic / diabetes

6 endpoints
Secondary/protocol endpoint

Change from Baseline in Fasting Glucose and HbA1c at Week 72

Time frame:Baseline and Week 72

change from baseline, improvement

componentsFasting glucose, change, HbA1c, change

Secondary/protocol endpoint

Change from Baseline in Systemic Insulin Sensitivity Indices

Time frame:Baseline and Week 72

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other/protocol endpoint

Percentage of Participants Reaching HbA1c Targets (< 7% and < 6.5%) at MTD

Time frame:72 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Other/protocol endpoint

Change From Baseline in HbA1c at MTD

Time frame:72 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Other/protocol endpoint

Change From Baseline in Fasting Glucose and HbA1c at Week 124

Time frame:Baseline and Week 124

change from baseline, improvement

componentsFasting glucose, change, HbA1c, change

Other/protocol endpoint

Change From Baseline in Insulin Sensitivity Indices (QUICKI, HOMA-IR, Matsuda) at Week 124

Time frame:Baseline and Week 124

HOMA-IR (insulin sensitivity)

change from baseline, improvement

MASH / liver

4 endpoints
Secondary/protocol endpoint

Change from Baseline in Liver Enzymes and Non-invasive Biomarkers (FLI, FIB-4)

Time frame:Baseline and Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Liver Stiffness and Fat Content at Week 72

Time frame:Baseline and Week 72

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Liver Enzymes at Week 124

Time frame:Baseline and Week 124

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Non-invasive Liver Scores (FLI and FIB-4) at Week 124

Time frame:Baseline and Week 124

change from baseline, improvement

Cardiometabolic biomarkers

8 endpoints
Secondary/protocol endpoint

Change from Baseline in Fasting Lipid Profile at Week 72

Time frame:Baseline and Week 72

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change from Baseline in Fasting Lipid Profile at Week 72

Time frame:Baseline and Week 72

change from baseline, improvement

componentsTotal cholesterol, change, LDL-C, change, HDL-C, change

Secondary/protocol endpoint

Change from Baseline in Systolic and Diastolic Blood Pressure

Time frame:Baseline and Week 72

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)

Time frame:Baseline and Week 72

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Other/protocol endpoint

Change From Baseline in Fasting Lipid Parameters at Week 124

Time frame:Baseline and Week 124

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Fasting Lipid Parameters at Week 124

Time frame:Baseline and Week 124

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Other/protocol endpoint

Change From Baseline in Blood Pressure

Time frame:Baseline and 124 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Other/protocol endpoint

Change From Baseline in hs-CRP at Week 124

Time frame:Baseline and week 124

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Patient-reported / QoL

8 endpoints
Secondary/protocol endpoint

Change From Baseline in the 36-Item Short Form Survey (SF-36) at Week 72

Time frame:Baseline and Week 72

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ)

Time frame:Baseline and Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)

Time frame:Baseline and Week 72

EQ-5D VAS

change from baseline, improvement

Secondary/protocol endpoint

Patient Global Impression of Severity (PGI-S) at Week 72

Time frame:Baseline and Week 72

PGI, change

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in the 36-Item Short Form Survey (SF-36) at Week 124

Time frame:Baseline and Week 124

SF-36 total

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in the PCOS Health-Related Quality of Life Questionnaire (PCOSQ) at Week 124

Time frame:Baseline and Week 124

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in EQ-5D-5L Health State Index Score at Week 124

Time frame:Baseline and Week 124

EQ-5D index

change from baseline, improvement

Other/protocol endpoint

Patient Global Impression of Severity (PGI-S) at Week 124

Time frame:Week 124

PGI, change

change from baseline, improvement

Other clinical outcomes

26 endpoints
Primary/protocol endpoint

Improvement of ovarian dysfunction as defined by menstrual irregularity in overweight or obesity-related PCOS

Time frame:At 72 weeks after randomization

Menstrual cyclicity

change from baseline, improvement

Primary/protocol endpoint

Key Secondary - Improvement of ovarian dysfunction as defined by ovulation frequency in overweight or obesity-related PCOS

Time frame:Within 24 weeks after completed dose titration

Ovulation rate

event count, improvement

Secondary/protocol endpoint

Percentage of Participants With Normalization of Menstrual Cycle

Time frame:Week 72

Menstrual cyclicity

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Serum Anti-Müllerian Hormone (AMH)

Time frame:Baseline and Week 72

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Biochemical Androgen Profile

Time frame:Baseline and Week 72

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Calculated Free Androgen Index (FAI) and Calculated Free Testosterone

Time frame:Baseline and Week 72

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Pituitary-Gonadal Hormones (LH, FSH, Estradiol, Progesterone)

Time frame:Baseline and Week 72

change from baseline, descriptive

Other/protocol endpoint

Dose-Dependent Menstrual Bleeding Ratio at Week 72

Time frame:Week 72

ratio, descriptive

Other/protocol endpoint

Dose-Dependent Change in Mean Menstrual Bleeding Ratio at Week 72

Time frame:Baseline and Week 72

change from baseline, improvement

Other/protocol endpoint

Dose-Dependent Normalization of Menstrual Cycle

Time frame:72 weeks

Menstrual cyclicity

threshold achievement, improvement

Other/protocol endpoint

Total Number of Biochemically Confirmed Ovulatory Events (Dose-Response)

Time frame:24 weeks following completed dose titration

Ovulation rate

event count, improvement

Other/protocol endpoint

Change From Baseline in Ovarian Volume (MTD vs. Placebo)

Time frame:72 weeks

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Follicle Number Per Ovary (MTD vs. Placebo)

Time frame:72 weeks

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Hirsutism (Ferriman-Gallwey Score) at MTD

Time frame:72 weeks

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Female Pattern Baldness (Ludwig Scale) at MTD

Time frame:72 weeks

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Acne Lesion Count at MTD

Time frame:72 weeks

change from baseline, improvement

Other/protocol endpoint

Menstrual Bleeding Ratio Within 52 Weeks After Drug Discontinuation

Time frame:Week 124

descriptive

Other/protocol endpoint/low confidence

Change in Menstrual Bleeding Ratio (Treatment vs. Follow-up)

Time frame:Week 72 to Week 124

change from baseline, improvement

Other/protocol endpoint

Percentage of Participants Maintaining Menstrual Cycle Normalization at Week 124

Time frame:Week 124

Menstrual cyclicity

threshold achievement, improvement

Other/protocol endpoint

Change From Baseline in Ovarian Volume (OV) and Follicle Number (FNPO) at Week 124

Time frame:Baseline and Week 124

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Serum Anti-Müllerian Hormone (AMH) at Week 124

Time frame:Baseline and Week 124

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Androgen Profile and Gonadotropins at Week 124

Time frame:Baseline and Week 124

Androgen, change

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Calculated Free Androgen Index (FAI) and Free Testosterone at Week 124

Time frame:Baseline and Week 124

Androgen, change

change from baseline, improvement

Other/protocol endpoint

Sustained Improvement in Hirsutism (Ferriman-Gallwey Score) at Week 124

Time frame:Baseline and Week 124

change from baseline, improvement

Other/protocol endpoint/low confidence

Sustained Improvement in Female Pattern Baldness (Ludwig Scale) and Acne at Week 124

Time frame:Baseline and Week 124

descriptive, improvement

Other/protocol endpoint

Clinical Pregnancy Rate at Week 124

Time frame:From Week 72 to Week 124

threshold achievement, improvement

Publications (10)

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.