Clinical trial NCT06577935: A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Postmenopausal Osteoporosis
Keywords: Osteoporosis
Lead sponsor: Angitia Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 350
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Percent change from Baseline to Month 12 in lumbar spine bone mineral density
timeFrame: 12 months
Secondary outcomes:
measure: Percent change from Baseline to Months 3 and 6 in lumbar spine, total hip, femoral neck, and one-third distal radius bone mineral density
timeFrame: 3 and 6 months
measure: Percent change from Baseline to Month 12 in total hip, femoral neck, and one-third distal radius bone mineral density
timeFrame: 12 months
measure: Percent change from Baseline to Months 1, 3, 6, 9, and 12 in P1NP and CTX-1
timeFrame: 1, 3, 6, 9, and 12 months
measure: Incidence of new clinical fractures (vertebral and nonvertebral) between Baseline and Month 12
timeFrame: 12 months
Other outcomes:
measure: Assessment of TEAEs (collection and documentation of all adverse events occurring during the study)
timeFrame: Baseline to 24 months
measure: Number of participants who develop anti-AGA2118 antibodies
timeFrame: Baseline to 24 months
measure: Evaluation of AGA2118 observed serum concentration levels for the AGA2118 treatment groups at Week 1 post-treatment and trough levels prior to dosing
timeFrame: Baseline to 24 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: Del Sol Research Management, LLC
state: Arizona
city: Gainesville
country: United States
facility: Center for Advanced Research & Education
state: Georgia
city: Cumberland
country: United States
facility: Klein & Associates, M.D., P.A.
state: Maryland
city: Missoula
country: United States
facility: Montana Medical Research, Inc
state: Montana
city: Albuquerque
country: United States
facility: NM Clinical Research & Osteoporosis Center, Inc.
state: New Mexico
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Burien
country: United States
facility: Puget Sound Osteoporosis Center
state: Washington
city: Buenos Aires
country: Argentina
facility: Centro Médico Arsema
city: Buenos Aires
country: Argentina
facility: Centro Médico Dra Laura Maffei e Investigación Cliínica Aplicada
city: Buenos Aires
country: Argentina
facility: Consultorio de Investigacion Clinica EMO SRL
city: Buenos Aires
country: Argentina
facility: IDIM
city: Buenos Aires
country: Argentina
facility: Investigaciones Reumatologicas y Osteologicas SRL
city: Buenos Aires
country: Argentina
facility: Stat Research
city: Barranquilla
country: Colombia
facility: Centro Integral De reumatologia del Caribe - CIRCARIBE SAS
city: Barranquilla
country: Colombia
facility: Centro de Investigación Médico Asistencial S.A.S. - CIMEDICAL S.A.S.
city: Bogota
country: Colombia
facility: Blue Care Salud SAS
city: Bogota
country: Colombia
facility: Centro de Investigacion en Reumatologia y Especialidades Medicas E.U. - CIREEM E.U
city: Bogota
country: Colombia
facility: Solano & Terront Servicios Médicos SAS - Unidad Integral de Endocrinología - UNIENDO
city: Gdynia
country: Poland
facility: Futuremeds Gdynia
city: Kraków
country: Poland
facility: Krakowskie Centrum Medyczne
city: Warszawa
country: Poland
facility: Futuremeds Warszawa Centrum
city: Warszawa
country: Poland
facility: Futuremeds Targowek
city: Wrocław
country: Poland
facility: Futuremeds Wroclaw
city: Łódź
country: Poland
facility: Futuremeds Lodz
Study officials:
affiliation: Angitia Incorporated Limited
name: Ricardo Dent-Acosta, MD
role: STUDY_DIRECTOR
References: