A Phase 2 Randomized Trial Evaluating Efficacy of AGA2118 in Postmenopausal Women with Low Bone Mass (ARTEMIS)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Angitia Inc. Ltd.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

11 Sep 2025 → ongoing

Decision date (initial)

2025-01-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Angitia Incorporated Limited

External identifiers

EU CT number

2024-515610-41-00

ClinicalTrials.gov

NCT06577935

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy, Others

To determine the effect of treatment with AGA2118 versus placebo at Month 12 on the percent change from Baseline in BMD at the lumbar spine in postmenopausal women with low BMD

Secondary objectives 3

1. To evaluate the effect of treatment with AGA2118 versus placebo at different timepoints on percent change from Baseline in BMD at the lumbar spine, total hip, femoral neck, and one-third distal radius
2. To evaluate the effect of treatment withAGA2118 versus placebo at different time points on percent change from Baseline in [CCI]
3. To evaluate the incidence of new clinical fractures (vertebral and nonvertebral) from Baseline to Month 12

Conditions and MedDRA coding

Postmenopausal Osteoporosis

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Healthy, ambulatory, postmenopausal women age >=55 to <=80
2. BMD T-score of <=-2.5 to >-3.5 at the lumbar spine, total hip, or femoral neck

Exclusion criteria 13

1. History of vertebral fracture, or fragility fracture of the wrist, humerus, proximal femur, or pelvis
2. Malignancy within the last 5 years
3. Use of agents affecting bone metabolism
4. Vitamin D deficiency
5. Known intolerance to calcium or vitamin D supplements
6. Untreated hyper- or hypothyroidism
7. Current hyper- or hypoparathyroidism
8. Elevated transaminases
9. Significantly impaired renal function
10. Current hypo- or hypercalcemia
11. Positive for HIV, hepatitis C virus, or hepatitis B surface antigen
12. Diagnosis of a familial cancer syndrome or known genetic mutation that increases risk of cancer
13. Myocardial infarction or stroke within the past 12 months

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percent change from Baseline to Month 12 in lumbar spine BMD

Secondary endpoints 4

1. Percent change from Baseline to Months 3 and 6 in lumbar spine, total hip, femoral neck, and one-third distal radius BMD
2. Percent change from Baseline to Month 12 in total hip, femoral neck, and one-third distal radius BMD
3. Percent change from Baseline to Months 1, 3, 6, 9, and 12 in [CCI]
4. Incidence of new clinical fractures (vertebral and nonvertebral) between Baseline and Month 12

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Angitia Inc. Ltd.

Sponsor organisation

Angitia Inc. Ltd.

Address

5850 Canoga Avenue Floor 4

City

Woodland Hills

Postcode

91367-6554

Country

United States

Scientific contact point

Organisation

Angitia Inc. Ltd.

Contact name

Ricardo Dent, MD

Public contact point

Organisation

Angitia Inc. Ltd.

Contact name

Deborah Lium

Third parties 12

Locations

4 EU/EEA countries · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 76 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications