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

NCT06577935 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ACT23-001
• Study Type: interventional
• Target: 379
• Locations: 4 countries
• Sites: 23

Brief Summary

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.

Conditions

Postmenopausal Osteoporosis

Keywords

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percent change from Baseline to Months 3 and 6 in lumbar spine, total hip, femoral neck, and one-third distal radius bone mineral density

  3 and 6 months

• Percent change from Baseline to Month 12 in total hip, femoral neck, and one-third distal radius bone mineral density

  12 months

• Percent change from Baseline to Months 1, 3, 6, 9, and 12 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

  12 months

Other Outcomes (3)

• 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

  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

  Baseline to 24 months

Study Arms (7)

AGA2118 Dose Regimen 1

EXPERIMENTAL

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

AGA2118 Dose Regimen 2

EXPERIMENTAL

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

AGA2118 Dose Regimen 3

EXPERIMENTAL

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

AGA2118 Dose Regimen 4

EXPERIMENTAL

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

AGA2118 Dose Regimen 5

EXPERIMENTAL

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

AGA2118 Dose Regimen 6

EXPERIMENTAL

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

Placebo Regimen

PLACEBO COMPARATOR

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

Interventions

AGA2118 DRUG

Subcutaneous injection

AGA2118 Dose Regimen 1; AGA2118 Dose Regimen 2; AGA2118 Dose Regimen 3; AGA2118 Dose Regimen 4; AGA2118 Dose Regimen 5; AGA2118 Dose Regimen 6

Placebo OTHER

Subcutaneous injection

Placebo Regimen

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angitia Biopharmaceuticals: lead

Study Sites (23)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Center for Advanced Research & Education

Gainesville, Georgia, 30501, United States

Location

NM Clinical Research & Osteoporosis Center, Inc.

Albuquerque, New Mexico, 87160, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Puget Sound Osteoporosis Center

Burien, Washington, 98166, United States

Location

Centro Médico Dra Laura Maffei e Investigación Cliínica Aplicada

Buenos Aires, Argentina, Argentina

Location

Consultorio de Investigacion Clinica EMO SRL

Buenos Aires, Argentina, Argentina

Location

IDIM

Buenos Aires, Argentina, Argentina

Location

Investigaciones Reumatologicas y Osteologicas SRL

Buenos Aires, Argentina, Argentina

Location

Mautalen - Salud e Investigacion (Expertia S.A.)

Buenos Aires, Argentina, Argentina

Location

Stat Research

Buenos Aires, Argentina, Argentina

Location

Instituto Médico Strusberg

Córdoba, Argentina, Argentina

Location

CIDIIM

Córdoba, Argentina

Location

Centro de Investigaciones Medicas Mar del Plata CIM

Mar del Plata, Argentina

Location

Futuremeds Gdynia

Gdynia, 81-384, Poland

Location

Krakowskie Centrum Medyczne

Krakow, 31-501, Poland

Location

Futuremeds Lodz

Lodz, 91-363, Poland

Location

Futuremeds Warszawa Centrum

Warsaw, 00-215, Poland

Location

Futuremeds Targowek

Warsaw, 03-291, Poland

Location

Futuremeds Wroclaw

Wroclaw, 53-673, Poland

Location

CE "Hospital #1" of Zhytomyr City Council

Kyiv, Ukraine, Ukraine

Location

Medical Center Universal Clinic "Oberig" of "Kapytal" LCC

Kyiv, Ukraine, Ukraine

Location

PSSE Medical Centre Pulse

Vinnytsia, Ukraine, Ukraine

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ricardo Dent-Acosta, MD

  Angitia Incorporated Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 29, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (5); UA (3); AR (9); PL (6)