Trial · NCT04581629
Safety, Tolerability, and Efficacy of Encaleret in Participants With Autosomal Dominant Hypocalcemia (ADH) Type 1
NCT04581629, Phase 2, Completed, Calcilytix Therapeutics, Inc., a BridgeBio company; results first posted 2024-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Tolerability, and Efficacy of Encaleret in Participants With Autosomal Dominant Hypocalcemia (ADH) Type 1. Trials, record NCT04581629. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04581629
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, and Efficacy of Encaleret in Participants With Autosomal Dominant Hypocalcemia (ADH) Type 1
- NCT number
- NCT04581629
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Calcilytix Therapeutics, Inc., a BridgeBio company
- Conditions
- Autosomal Dominant Hypocalcemia (ADH), Autosomal Dominant Hypocalcemia Type 1 (ADH1)
- Interventions
- Encaleret
- First posted
- 2020-10-09
- Last updated
- 2024-11-19
- Results first posted
- 2024-11-19
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Periods 1, 2 and 3: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to 16 months | Adverse events (AEs) were defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Treatment-emergence was defined as any AE(s) regardless of relationship to investigational medicinal product (IMP), that had an onset or worsened in severity on or after the first dose of IMP. |
| Primary | Period 3: Change From Baseline in Albumin-Corrected Blood Calcium Concentrations (cCa) | Baseline, Week 24 | |
| Primary | Period 3: Rate of Urinary Calcium Excretion | Week 24 | |
| Secondary | Periods 1 and 2: Intact Parathyroid Hormone (iPTH) Concentrations in the Blood | 15 minutes pre-dose on Day 5 of Periods 1 and 2 (Periods were 5 days) | Blood samples were taken for analysis of iPTH concentrations. iPTH concentrations were analyzed via an electrochemiluminescence immunoassay. |
| Secondary | Periods 1 and 2: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Encaleret | Periods 1 and 2: Day 5 (Periods were 5 days) | |
| Secondary | Periods 1, 2 and 3: Maximum Plasma Concentration (Cmax) of Encaleret | Periods 1 and 2: Day 5, Period 3: Week 24 (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3) | |
| Secondary | Periods 1, 2 and 3: Time to Maximum Plasma Concentration (Tmax) of Encaleret | Periods 1 and 2: Day 5; Period 3: Week 24 (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3) | |
| Secondary | Periods 2 and 3: Change From Baseline in Blood Calcium Concentration (cCa) | Period 2: Baseline, Day 5 (Period was 5 days), Period 3: Baseline, Week 24 (Period was 24 weeks) | Data values presented are for the change from baseline for the average values at the specified timepoints/visits. |
| Secondary | Period 3: Urinary Calcium Clearance as Assessed by Fractional Excretion | Period 3: Week 24, 15 minutes pre-dose (Period was 24 weeks) | Fractional Excretion of Calcium was derived as (Urine Calcium at the interval considered \* Serum Creatinine at the end of the interval considered)/(Serum Calcium at the end of the interval considered \* Urine Creatinine at the interval considered) and is presented as percentage. |
| Secondary | Periods 1, 2 and 3: Urinary Calcium Clearance as Assessed by 24-Hour Total Excretion | Periods 1 and 2: Day 5; Period 3, Week 24 (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3) |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Periods 1, 2 and 3: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to 16 months | Safety Analysis Set included all participants who received at least one dose of study drug in the considered period. As pre-specified in the protocol, data were collected and are presented pooled for Periods 2 and 3. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Period 3: Change From Baseline in Albumin-Corrected Blood Calcium Concentrations (cCa) | Baseline, Week 24 | Safety Analysis Set included all participants who received at least one dose of study drug in the considered period. As pre-specified in the protocol, data are presented for Period 3 only. As pre-specified, data were collected and are reported pooled for all dose levels in Period 3 and are presented at the specified timepoint. | milligrams (mg)/deciliter (dL) | MEAN |
| PRIMARY | Period 3: Rate of Urinary Calcium Excretion | Week 24 | Safety Analysis Set included all participants who received at least one dose of study drug in the considered period. As pre-specified in the protocol, data are presented for Period 3 only. Number analyzed = number of participants evaluable at the specified timepoint. As pre-specified, data were collected and are reported pooled for all dose levels in Period 3 and are presented at the specified timepoint. | mg/24hour (hr) | MEAN |
| SECONDARY | Periods 1 and 2: Intact Parathyroid Hormone (iPTH) Concentrations in the Blood | 15 minutes pre-dose on Day 5 of Periods 1 and 2 (Periods were 5 days) | Safety Analysis Set, all participants who received at least 1 dose of study drug in the considered period. As pre-specified in the protocol, data are presented for Periods 1 and 2 only. Overall number of participants analyzed=those evaluable for this endpoint. Number analyzed=those evaluable at specified timepoints. As pre-specified, data were collected and reported pooled for all dose levels in Period 2 at the specified timepoint and per dose at the specified timepoint in Period 1. | Picograms (pg)/milliliter (mL) | MEAN |
| SECONDARY | Periods 1 and 2: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Encaleret | Periods 1 and 2: Day 5 (Periods were 5 days) | Pharmacokinetic (PK) Analysis Set included all participants who received at least one dose of study drug and who had at least one non-missing PK concentration result. Overall number of participants analyzed = participants evaluable for this endpoint. Number analyzed = participants evaluable for this endpoint at the specified timepoints. As pre-specified in the protocol, data are presented for Periods 1 and 2 only. | hour (hr)*nanogram (ng)/milliliter (mL) | MEAN |
| SECONDARY | Periods 1, 2 and 3: Maximum Plasma Concentration (Cmax) of Encaleret | Periods 1 and 2: Day 5, Period 3: Week 24 (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3) | Pharmacokinetic (PK) Analysis Set included all participants who received at least one dose of study drug and who had at least one non-missing PK concentration result. Overall number of participants analyzed = participants evaluable for the endpoint. Number analyzed = participants evaluable for the endpoint at the specified timepoints. As pre-specified in the protocol, data for Periods 2 and 3 are reported per dose received. | nanograms (ng)/milliliter (mL) | MEAN |
| SECONDARY | Periods 1, 2 and 3: Time to Maximum Plasma Concentration (Tmax) of Encaleret | Periods 1 and 2: Day 5; Period 3: Week 24 (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3) | Pharmacokinetic (PK) Analysis Set included all participants who received at least one dose of study drug and who had at least one non-missing PK concentration result. Overall number of participants analyzed = participants evaluable for the endpoint. Number analyzed = participants evaluable for the endpoint at the specified timepoints. As pre-specified in the protocol, data for Periods 2 and 3 are reported per dose received. | hour | MEDIAN |
| SECONDARY | Periods 2 and 3: Change From Baseline in Blood Calcium Concentration (cCa) | Period 2: Baseline, Day 5 (Period was 5 days), Period 3: Baseline, Week 24 (Period was 24 weeks) | Safety Analysis Set included all participants who received at least one dose of study drug in the considered period. As pre-specified in the protocol, data are presented for Periods 2 and 3 only. Number analyzed = participants evaluable for the endpoint at the specified timepoints. As pre-specified, data were collected and are reported pooled for all dose levels in Period 2 and Period 3 and are presented at the specified timepoints. | milligram (mg)/ deciliter (dL) | MEAN |
| SECONDARY | Period 3: Urinary Calcium Clearance as Assessed by Fractional Excretion | Period 3: Week 24, 15 minutes pre-dose (Period was 24 weeks) | Safety Analysis Set included all participants who received at least one dose of study drug in the considered period. Number analyzed = participants evaluable for the endpoint at the specified timepoints. As pre-specified, data were collected and are reported pooled for all dose levels in Period 3 and are presented at the specified timepoint. | percentage | MEAN |
| SECONDARY | Periods 1, 2 and 3: Urinary Calcium Clearance as Assessed by 24-Hour Total Excretion | Periods 1 and 2: Day 5; Period 3, Week 24 (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3) | Safety Analysis Set, which included all participants who received at least one dose of study drug in the considered period. Number analyzed = participants evaluable for the endpoint at the specified timepoints. As pre-specified, data were collected and are reported pooled for all dose levels in Period 2 and Period 3 at the specified timepoints. As pre-specified, data were collected and are presented per dose at the specified timepoint for Period 1. | mg/24hr | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group126
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Periods 1, 2 and 3: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Period 1: Encaleret | 5 | Participants | ||
| Periods 1, 2 and 3: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Periods 2 and 3: Encaleret | 13 | Participants | ||
| Period 3: Change From Baseline in Albumin-Corrected Blood Calcium Concentrations (cCa) | Period 3: Encaleret | 1.9 | Standard Deviation 0.48 | milligrams (mg)/deciliter (dL) | |
| Period 3: Rate of Urinary Calcium Excretion | Period 3: Encaleret | 202 | Standard Deviation 83 | mg/24hour (hr) | |
| Periods 1 and 2: Intact Parathyroid Hormone (iPTH) Concentrations in the Blood | Period 1: Encaleret | Period 1: Day 5 (180 mg) | 43.8 | Standard Deviation 34.06 | Picograms (pg)/milliliter (mL) |
| Periods 1 and 2: Intact Parathyroid Hormone (iPTH) Concentrations in the Blood | Period 2: Encaleret | Period 2: Day 5 | 20.6 | Standard Deviation 15.87 | Picograms (pg)/milliliter (mL) |
| Periods 1 and 2: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Encaleret | Period 1: Encaleret | Period 1: Day 5 AM 180mg | 11283.7 | Standard Deviation 3556.12 | hour (hr)*nanogram (ng)/milliliter (mL) |
| Periods 1 and 2: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Encaleret | Period 1: Encaleret | Period 1: Day 5 PM 180 mg | 13127.7 | Standard Deviation 2992.61 | hour (hr)*nanogram (ng)/milliliter (mL) |
| Periods 1 and 2: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Encaleret | Period 1: Encaleret | Period 1: Day 5 PM 120 mg | 12417.0 | Standard Deviation NA | hour (hr)*nanogram (ng)/milliliter (mL) |
| Periods 1 and 2: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Encaleret | Period 2: Encaleret | Period 2: Day 5 PM 10mg | 623.7 | Standard Deviation NA | hour (hr)*nanogram (ng)/milliliter (mL) |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (5 Days) | STARTED | Period 1: Encaleret | 6 | |
| Period 1 (5 Days) | STARTED | Period 2: Encaleret | 0 | |
| Period 1 (5 Days) | STARTED | Period 3: Encaleret | 0 | |
| Period 1 (5 Days) | Received at Least One Dose of Study Treatment | Period 1: Encaleret | 6 | |
| Period 1 (5 Days) | Received at Least One Dose of Study Treatment | Period 2: Encaleret | 0 | |
| Period 1 (5 Days) | Received at Least One Dose of Study Treatment | Period 3: Encaleret | 0 | |
| Period 1 (5 Days) | COMPLETED | Period 1: Encaleret | 6 | |
| Period 1 (5 Days) | COMPLETED | Period 2: Encaleret | 0 | |
| Period 1 (5 Days) | COMPLETED | Period 3: Encaleret | 0 | |
| Period 1 (5 Days) | NOT COMPLETED | Period 1: Encaleret | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events88
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Period 1: Encaleret | 0 | 6 | |
| other | Upper respiratory tract infection | Infections and infestations | Periods 2 and 3: Encaleret | 4 | 13 | |
| other | Vulvovaginal mycotic infection | Infections and infestations | Period 1: Encaleret | 0 | 3 | |
| other | Vulvovaginal mycotic infection | Infections and infestations | Periods 2 and 3: Encaleret | 3 | 8 | |
| other | Pharyngitis | Infections and infestations | Period 1: Encaleret | 1 | 6 | |
| other | Pharyngitis | Infections and infestations | Periods 2 and 3: Encaleret | 1 | 13 | |
| other | Bacterial vaginosis | Infections and infestations | Period 1: Encaleret | 0 | 3 | |
| other | Bacterial vaginosis | Infections and infestations | Periods 2 and 3: Encaleret | 1 | 8 | |
| other | Chronic sinusitis | Infections and infestations | Period 1: Encaleret | 0 | 6 | |
| other | Chronic sinusitis | Infections and infestations | Periods 2 and 3: Encaleret | 1 | 13 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Period 1: Encaleret | 0 | 6 |
| Total, all-cause mortality | Periods 2 and 3: Encaleret | 0 | 13 |
| Total, other adverse events | Period 1: Encaleret | 5 | 6 |
| Total, other adverse events | Periods 2 and 3: Encaleret | 13 | 13 |
| Total, serious adverse events | Period 1: Encaleret | 0 | 6 |
| Total, serious adverse events | Periods 2 and 3: Encaleret | 0 | 13 |
Source ClinicalTrials.gov
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Period 1: Encaleret vs Periods 2 and 3: Encaleret: Periods 1, 2 and 3: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Trial comparisons |
| Period 1: Encaleret vs Periods 2 and 3: Encaleret: deaths from any cause | Trial comparisons |
| Period 1: Encaleret vs Periods 2 and 3: Encaleret: serious adverse events | Trial comparisons |
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/NCT04581629
GET https://conductscience.org/api/trials/v1/NCT04581629/results?page=2