Trial · NCT06547151
Evaluating the Safety and Efficacy of AMOR-1 as a Treatment for Hypocalcemia Associated With Hypoparathyroidism in Adults
NCT06547151, Phase 2, Active not recruiting, Amorphical Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluating the Safety and Efficacy of AMOR-1 as a Treatment for Hypocalcemia Associated With Hypoparathyroidism in Adults. Trials, record NCT06547151. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06547151
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating the Safety and Efficacy of AMOR-1 as a Treatment for Hypocalcemia Associated With Hypoparathyroidism in Adults
- NCT number
- NCT06547151
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 62 participants, actual
- Lead sponsor
- Amorphical Ltd.
- Conditions
- Hypoparathyroidism
- Interventions
- AMOR-1, Crystalline Calcium Carbonate
- First posted
- 2024-08-09
- Last updated
- 2026-08-14
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Who Achieved the Primary Composite Endpoint at Week 14 | 14 weeks | The composite efficacy endpoint is defined as: Subject had a reduction from baseline in total daily dose of oral calcium supplementation of at least 50%, and an albumin-adjusted total serum calcium concentration level between 8.0 mg/dL (incl.) and 10.0 mg/dL (incl.), and no increase from baseline in vitamin D metabolite/analog |
| Secondary | Albumin-adjusted serum calcium | Week 4 to Week 14 | Proportion of participants who achieved albumin-adjusted serum calcium concentrations above, below, or in the range of 8.0 mg/dl and 10.0 mg/dl during Dose Maintenance. |
| Secondary | Urinary Calcium Excretion | Week 14 | Change From Baseline in Urinary Calcium Excretion |
| Secondary | Urine calcium excretion above 300mg/24h | Week 4 to Week 14 | Incidence of increase in urine calcium excretion (\>300 mg/24h) during Dose Maintenance |
| Secondary | GI symptoms | Week 4 to Week 14 | Incidence of GI symptoms associated with calcium intake |
| Secondary | Symptoms associated with hypocalcemia | Week 4 to Week 14 | Incidence of symptoms associated with hypocalcemia |
| Secondary | Hypoparathyroidism Patient Experience Scale (HPES)- Experience (HPES) - Symptom | Week 14 | Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) - Symptom total score at Week 14 |
| Secondary | HPES - Impact | Week 14 | Change from baseline in HPES - Impact total score at Week 14 |
| Secondary | HPES - Symptom - Physical Domain | Week 14 | Change from baseline HPES - Symptom - Physical Domain score at Week 14 |
| Secondary | HPES - Symptom - Cognitive Domain | Week 14 | Change from baseline in HPES - Symptom - Cognitive Domain score at Week 14 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06547151
GET https://conductscience.org/api/trials/v1/NCT06547151/registered