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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Postmenopausal Osteoporosis
• Intervention / Treatment: Other: Placebo; Drug: AGA2118

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 379
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina
    • CIDIIM
  • Mar del Plata, Argentina
    • Centro de Investigaciones Medicas Mar del Plata CIM
  • Argentina
    • Buenos Aires, Argentina, Argentina
      • Centro Médico Dra Laura Maffei e Investigación Cliínica Aplicada
    • Buenos Aires, Argentina, Argentina
      • Consultorio de Investigacion Clinica EMO SRL
    • Buenos Aires, Argentina, Argentina
      • IDIM
    • Buenos Aires, Argentina, Argentina
      • Investigaciones Reumatologicas y Osteologicas SRL
    • Buenos Aires, Argentina, Argentina
      • Mautalen - Salud e Investigacion (Expertia S.A.)
    • Buenos Aires, Argentina, Argentina
      • Stat Research
    • Córdoba, Argentina, Argentina
      • Instituto Médico Strusberg
• Poland
  • Gdynia, Poland, 81-384
    • FutureMeds Gdynia
  • Krakow, Poland, 31-501
    • Krakowskie Centrum Medyczne
  • Lodz, Poland, 91-363
    • FutureMeds Lodz
  • Warsaw, Poland, 03-291
    • FutureMeds Targowek
  • Warsaw, Poland, 00-215
    • FutureMeds Warszawa Centrum
  • Wroclaw, Poland, 53-673
    • FutureMeds Wroclaw
• Ukraine
  • Ukraine
    • Kyiv, Ukraine, Ukraine
      • CE "Hospital #1" of Zhytomyr City Council
    • Kyiv, Ukraine, Ukraine
      • Medical Center Universal Clinic "Oberig" of "Kapytal" LCC
    • Vinnytsia, Ukraine, Ukraine
      • PSSE Medical Centre Pulse
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Center for Advanced Research & Education
  • New Mexico
    • Albuquerque, New Mexico, United States, 87160
      • NM Clinical Research & Osteoporosis Center, Inc.
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research
  • Washington
    • Burien, Washington, United States, 98166
      • Puget Sound Osteoporosis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: AGA2118; Subcutaneous injection
Experimental: AGA2118 Dose Regimen 2; 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.	Drug: AGA2118; Subcutaneous injection
Experimental: AGA2118 Dose Regimen 3; 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.	Drug: AGA2118; Subcutaneous injection
Experimental: AGA2118 Dose Regimen 4; 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.	Drug: AGA2118; Subcutaneous injection
Experimental: AGA2118 Dose Regimen 5; 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.	Drug: AGA2118; Subcutaneous injection
Experimental: AGA2118 Dose Regimen 6; 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.	Drug: AGA2118; Subcutaneous injection
Placebo Comparator: 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.	Other: Placebo; Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change from Baseline to Month 12 in lumbar spine bone mineral density	To determine the effect of treatment with AGA2118 versus placebo at Month 12 on the percent change from Baseline in bone mineral density at the lumbar spine in postmenopausal women with low bone mineral density	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change from Baseline to Months 3 and 6 in lumbar spine, total hip, femoral neck, and one-third distal radius bone mineral density	To evaluate the effect of treatment with AGA2118 versus placebo at different timepoints on percent change from Baseline in bone mineral density at the lumbar spine, total hip, femoral neck, and one-third distal radius	3 and 6 months
Percent change from Baseline to Month 12 in total hip, femoral neck, and one-third distal radius bone mineral density	To evaluate the effect of treatment with AGA2118 versus placebo at different timepoints on percent change from Baseline in bone mineral density at the lumbar spine, total hip, femoral neck, and one-third distal radius	12 months
Percent change from Baseline to Months 1, 3, 6, 9, and 12 in P1NP and CTX-1	To evaluate the effect of treatment with AGA2118 versus placebo at different time points on percent change from Baseline in P1NP and CTX-1	1, 3, 6, 9, and 12 months
Incidence of new clinical fractures (vertebral and nonvertebral) between Baseline and Month 12	To evaluate the incidence of new clinical fractures (vertebral and nonvertebral) from Baseline to Month 12	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of TEAEs (collection and documentation of all adverse events occurring during the study)		Baseline to 24 months
Number of participants who develop anti-AGA2118 antibodies	To assess the formation of anti-AGA2118 antibodies	Baseline to 24 months
Evaluation of AGA2118 observed serum concentration levels for the AGA2118 treatment groups at Week 1 post-treatment and trough levels prior to dosing	To characterize the pharmacokinetic parameters of the different AGA2118 doses	Baseline to 24 months

Collaborators and Investigators

• Sponsor: Angitia Biopharmaceuticals
• Investigators: Study Director: Ricardo Dent-Acosta, MD, Angitia Incorporated Limited

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Osteoporosis
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases, Metabolic; Nutritional and Metabolic Diseases; Osteoporosis; Osteoporosis, Postmenopausal
• Other Study ID Numbers: ACT23-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No