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

Angitia Biopharmaceuticals

Status and phase: Not yet enrolling; Phase 2

Conditions: Postmenopausal Osteoporosis

Treatments: Other: Placebo; Drug: AGA2118

Study type: Interventional

Funder types: Industry

Identifiers

NCT06577935

ACT23-001

Details and patient eligibility

About

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.

Full 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 surveyed throughout Months 12 to 24.

Enrollment: 350 estimated patients

Sex: Female

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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.
• Use of agents affecting bone metabolism.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

350 participants in 7 patient groups, including a placebo group

AGA2118 Dose Regimen 1

Experimental group

Description:

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.

Treatment:

Drug: AGA2118

AGA2118 Dose Regimen 2

Experimental group

Description:

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.

Treatment:

Drug: AGA2118

AGA2118 Dose Regimen 3

Experimental group

Description:

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.

Treatment:

Drug: AGA2118

AGA2118 Dose Regimen 4

Experimental group

Description:

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.

Treatment:

Drug: AGA2118

AGA2118 Dose Regimen 5

Experimental group

Description:

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.

Treatment:

Drug: AGA2118

AGA2118 Dose Regimen 6

Experimental group

Description:

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.

Treatment:

Drug: AGA2118

Placebo Regimen

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo