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NCT06577935

A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS)

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2027-08-31

Brief Summary

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The primary objective of this study is to determine the effect of treatment with AGA2118 versus placebo at Month 12 on lumbar spine bone mineral density (BMD) in postmenopausal women with low bone mass.

Detailed Description

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This Phase 2 dose-finding study will evaluate the safety, tolerability, and efficacy of AGA2118 at a range of dosing regimens in postmenopausal women with low BMD at the lumbar spine, total hip, or femoral neck and no prior history of fragility fractures.

This study includes a 12 month blinded treatment phase where participants will be randomized 1:1:1:1:1:1:1 to receive double-blind dosing regimens of AGA2118 or placebo. At Month 12, participants who have completed the double-blind portion of the study will continue on to a 12 month open-label period where they will be re-randomized based on their prior dosing regimen to either continue their current dosing regimen, receive a new dosing regimen, or discontinue treatment and be actively surveilled throughout Months 12 to 24.

Conditions

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Postmenopausal Osteoporosis

Keywords

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AGA2118 Dose Regimen 1

AGA2118 selected dose

Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.

Group Type EXPERIMENTAL

AGA2118

Intervention Type DRUG

Subcutaneous injection

AGA2118 Dose Regimen 2

Group Type EXPERIMENTAL

AGA2118

Intervention Type DRUG

Subcutaneous injection

AGA2118 Dose Regimen 3

Group Type EXPERIMENTAL

AGA2118

Intervention Type DRUG

Subcutaneous injection

AGA2118 Dose Regimen 4

Group Type EXPERIMENTAL

AGA2118

Intervention Type DRUG

Subcutaneous injection

AGA2118 Dose Regimen 5

Group Type EXPERIMENTAL

AGA2118

Intervention Type DRUG

Subcutaneous injection

AGA2118 Dose Regimen 6

Group Type EXPERIMENTAL

AGA2118

Intervention Type DRUG

Subcutaneous injection

Placebo Regimen

Placebo selected dose

Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Subcutaneous injection

Interventions

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AGA2118

Subcutaneous injection

Intervention Type DRUG

Placebo

Subcutaneous injection

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ricardo Dent-Acosta, MD

Role: STUDY_DIRECTOR

Angitia Incorporated Limited

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Del Sol Research Management, LLC

Tucson, Arizona, United States

Site Status WITHDRAWN

Center for Advanced Research & Education

Gainesville, Georgia, United States

Site Status RECRUITING

Klein & Associates, M.D., P.A.

Cumberland, Maryland, United States

Site Status WITHDRAWN

Montana Medical Research, Inc

Missoula, Montana, United States

Site Status WITHDRAWN

NM Clinical Research & Osteoporosis Center, Inc.

Albuquerque, New Mexico, United States

Site Status RECRUITING

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status RECRUITING