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Evaluating AGA2118 for treating low bone mass in postmenopausal women

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Safety, Tolerability and Efficacy of AGA2118 in Postmenopausal Women With Low Bone Mineral Density

Phase 2 Interventional Angitia Biopharmaceuticals · NCT06577935

This study is testing a new treatment called AGA2118 to see if it can help postmenopausal women aged 55 to 80 with low bone density improve their bone health over a year.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment350 (estimated)
Ages55 Years to 80 Years
SexFemale
SponsorAngitia Biopharmaceuticals Industry-sponsored
Locations19 sites (Birmingham, Alabama and 18 other locations)
Trial IDNCT06577935 on ClinicalTrials.gov

What this trial studies

This Phase 2 trial aims to assess the efficacy, safety, and tolerability of AGA2118 in postmenopausal women aged 55 to 80 with low bone mineral density (BMD). Participants will be randomized to receive either AGA2118 or a placebo over a 12-month blinded treatment phase, followed by a 12-month open-label period. The primary outcome is the change in lumbar spine BMD at Month 12. The study excludes individuals with a history of fragility fractures and certain medical conditions that could affect bone metabolism.

Who should consider this trial

Good fit: Ideal candidates are healthy, ambulatory postmenopausal women aged 55 to 80 with a BMD T-score between -2.5 and -3.5.

Not a fit: Patients with a history of fragility fractures or significant medical conditions affecting bone health may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve bone density and reduce the risk of fractures in postmenopausal women with osteoporosis.

How similar studies have performed: Similar studies evaluating treatments for postmenopausal osteoporosis have shown promising results, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Healthy, ambulatory, postmenopausal women age ≥ 55 to ≤ 80.
* BMD T-score of ≤ -2.5 to \> -3.5 at the lumbar spine, total hip, or femoral neck.

Exclusion Criteria:

* History of vertebral fracture, or fragility fracture of the wrist, humerus, proximal femur, or pelvis.
* Vitamin D deficiency.
* Known intolerance to calcium or vitamin D supplements.
* Untreated hyper- or hypothyroidism.
* Current hyper- or hypoparathyroidism.
* Elevated transaminases.
* Significantly impaired renal function.
* Current hypo- or hypercalcemia.
* Positive for HIV, hepatitis C virus, or hepatitis B surface antigen.
* Malignancy within the last 5 years.
* Diagnosis of a familial cancer syndrome or known genetic mutation that increases risk of cancer.
* Myocardial infarction or stroke within the past 12 months.
* Use of agents affecting bone metabolism.

Where this trial is running

Birmingham, Alabama and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Postmenopausal OsteoporosisOsteoporosis
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.