Postmenopausal OsteoporosisPhase 2ARTEMISNCT06577935
A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS)
A Phase 2 study testing AGA2118 in people with Postmenopausal Osteoporosis, run by Angitia Biopharmaceuticals at 23 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- AGA2118
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 379 participants
- Where
- 23 sitesin 4 countries
- Study dates
- 31 Oct 2024to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
Argentina9 sites
Centro Médico Dra Laura Maffei e Investigación Cliínica Aplicada
Buenos Aires, Argentina
Consultorio de Investigacion Clinica EMO SRL
Buenos Aires, Argentina
IDIM
Buenos Aires, Argentina
Investigaciones Reumatologicas y Osteologicas SRL
Buenos Aires, Argentina
Mautalen - Salud e Investigacion (Expertia S.A.)
Buenos Aires, Argentina
Stat Research
Buenos Aires, Argentina
Instituto Médico Strusberg
Córdoba, Argentina
CIDIIM
Córdoba
Centro de Investigaciones Medicas Mar del Plata CIM
Mar del Plata
Poland6 sites
Futuremeds Gdynia
Gdynia, 81-384
Krakowskie Centrum Medyczne
Krakow, 31-501
Futuremeds Lodz
Lodz, 91-363
Futuremeds Warszawa Centrum
Warsaw, 00-215
Futuremeds Targowek
Warsaw, 03-291
Futuremeds Wroclaw
Wroclaw, 53-673
United States5 sites
NM Clinical Research & Osteoporosis Center, Inc.
Albuquerque, New Mexico, 87160
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Puget Sound Osteoporosis Center
Burien, Washington, 98166
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Center for Advanced Research & Education
Gainesville, Georgia, 30501
Ukraine3 sites
CE "Hospital #1" of Zhytomyr City Council
Kyiv, Ukraine
Medical Center Universal Clinic "Oberig" of "Kapytal" LCC
Kyiv, Ukraine
PSSE Medical Centre Pulse
Vinnytsia, Ukraine
About this study
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
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.
Read the 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.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- AGA2118, Placebo
- Keywords
- Osteoporosis
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGA2118Drug
Subcutaneous injection
PlaceboOther
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start31 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angitia Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ricardo Dent-Acosta, MD, Study director, Angitia Incorporated Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577935
- Sponsor's protocol ID
- ACT23-001
- Acronym
- ARTEMIS
- Status last verified
- Feb 2026
- First submitted
- 14 Aug 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06577935
- Acronym / sponsor ID
- ARTEMIS / ACT23-001
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Angitia BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| AGA2118 Dose Regimen 1 | Experimental | Drug: AGA2118AGA2118 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. |
| AGA2118 Dose Regimen 2 | Experimental | Drug: AGA2118AGA2118 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. |
| AGA2118 Dose Regimen 3 | Experimental | Drug: AGA2118AGA2118 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. |
| AGA2118 Dose Regimen 4 | Experimental | Drug: AGA2118AGA2118 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. |
| AGA2118 Dose Regimen 5 | Experimental | Drug: AGA2118AGA2118 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. |
| AGA2118 Dose Regimen 6 | Experimental | Drug: AGA2118AGA2118 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. |
| Placebo Regimen | Placebo comparator | Other: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGA2118Subcutaneous injection | Drug | AGA2118 Dose Regimen 1, AGA2118 Dose Regimen 2, AGA2118 Dose Regimen 3, AGA2118 Dose Regimen 4, AGA2118 Dose Regimen 5, AGA2118 Dose Regimen 6 |
| PlaceboSubcutaneous injection | Other | Placebo Regimen |
Primary outcome
Percent change from Baseline to Month 12 in lumbar spine bone mineral density
Time frame: 12 months
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
4 secondary outcomes
Percent change from Baseline to Months 3 and 6 in lumbar spine, total hip, femoral neck, and one-third distal radius bone mineral density
Time frame: 3 and 6 months
Percent change from Baseline to Month 12 in total hip, femoral neck, and one-third distal radius bone mineral density
Time frame: 12 months
Percent change from Baseline to Months 1, 3, 6, 9, and 12 in P1NP and CTX-1
Time frame: 1, 3, 6, 9, and 12 months
Incidence of new clinical fractures (vertebral and nonvertebral) between Baseline and Month 12
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Dent-Acosta, MD study director
Angitia Incorporated Limited
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AGA2118 in people with Postmenopausal Osteoporosis, run by Angitia Biopharmaceuticals at 23 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Argentina, Poland, United States, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from Baseline to Month 12 in lumbar spine bone mineral density (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.