DelfaGLP-1 Atlas

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CompletedPhase 2

Exenatide and Metformin Therapy in Overweight Women With PCOS

Comparison of the Effects of Monotherapy With Exenatide or Metformin to Combined Exenatide and Metformin Therapy on Menstrual Cyclicity in Overweight Women With Polycystic Ovary Syndrome

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

60

actual

Study population

Obesity / overweight, PCOS

Key I/E criteria

•BMI ≥27•Female

Primary endpoint

•Menstrual cyclicity

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 IDNCT00344851
Org study IDRP06-010

Timeline

Milestones

Study first posted2006-06-27estimated
Last update posted2007-07-11estimated
Study start2006-06 (month precision)
Study completion2007-06actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightPCOS

Eligibility

Who can enroll

Minimum age18 Years
Maximum age40 Years
SexFemale
Healthy volunteersAccepted

Inclusion criteria

Overweight/obese women (BMI>27)

1. Must have six or fewer menses /year or be amenorrheic

2. Have either clinical or laboratory evidence of hyperandrogenism (hirsutism or elevated testosterone (T)) and /or PCOS ovary on ultrasound

Exclusion criteria

other uncorrected endocrinopathy- hyperprolactinemia, hyper- or hypothyroidism, congenital adrenal hyperplasia or presence of overt diabetes alterations in hepatic or renal function use of hormonal medications, insulin sensitizers or medications that interfere with carbohydrate metabolism for at least 8 weeks Known active substance abuse including tobacco and alcohol. Pregnancy, breastfeeding or desire for pregnancy during study interval (6 months

Endpoints (5)

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

Glycemic / diabetes
3
Weight & body composition
1
Other clinical outcomes
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

BMI, WHR, FAI (T/SHBG), DHEAS, lipids,abdominal girth,

Time frame:BMI,WHR,abdominal girth at start,12 weeks and 24 weeks, FAI, DHEAS, lipids at start and at 24 weeks

BMI, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

insulin resistance-(HOMA and composite insulin sensitivity index [ SIOGTT),

Time frame:at start and at 24 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

and pancreatic ß-cell function (corrected insulin response [CIRgp] and

Time frame:at start and at 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

insulinogenic index [IGI] ).

Time frame:at start and at 24 weeks

descriptive

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

- Menstrual Cyclicity ( # menses/ 24 weeks)

Time frame:every 4 weeks

Menstrual cyclicity

event count, improvement

Publications (1)

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.