Trial · NCT05823012
Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism
NCT05823012, Phase 2, Completed, Xeris Pharmaceuticals; results first posted 2025-07-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism. Trials, record NCT05823012. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05823012
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism
- NCT number
- NCT05823012
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- Xeris Pharmaceuticals
- Conditions
- Hypothyroidism
- Interventions
- levothyroxine sodium
- First posted
- 2023-04-21
- Last updated
- 2025-07-03
- Results first posted
- 2025-07-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Conversion Factor | Day 29 of the Maintenance Period | Geometric mean ratio of the weekly dose of XP-8121 to the daily dose of oral levothyroxine (aka dose conversion factor), where the XP-8121 dose corresponds to the administration immediately preceding collection of blood TSH used to determine normalization at the end of Maintenance Period. The dose conversion factor was assessed by comparing the natural log-transformed final XP-8121 dose in μg that maintained normalized TSH throughout the Maintenance Period to the natural log-transformed daily oral levothyroxine dose the participant was taking before the study, using a linear mixed effects model with treatment as the fixed effect and subject as the random effect. Geometric least square means (LSMs) were calculated by exponentiating the LSM from the ANOVA. The geometric mean ratio and the corresponding 90% CI was found by exponentiating the differences of log-transformed LSM and 90% confidence interval (CI) of the difference. |
| Primary | Tolerability Assessment: Modified Draize Scale - Erythema | Week 1 Dosing in Titration Period through Day 22 Dosing in Maintenance Period | The Modified Draize Scale assessment of erythema and edema was conducted 30 (+/-5) minutes after each dosing. The Modified Draize Scale is a 5-point scale: 0-none, 1-very slight, 2-slight, 3-moderate, 4-severe. |
| Primary | Tolerability Assessment: Modified Draize Scale - Edema | Week 1 Dosing in Titration Period through Day 22 Dosing in Maintenance Period | The Modified Draize Scale assessment of erythema and edema was conducted 30 (+/-5) minutes after each dosing. The Modified Draize Scale is a 5-point scale: 0-none, 1-very slight, 2-slight, 3-moderate, 4-severe. |
| Primary | Tolerability Assessments: Injection Site Discomfort Evaluation | Week 1 dosing in the Titration Period through Day 22 dosing in the Maintenance Period | Injection site discomfort was assessed by each participant at 10 (+/-2) minutes post-injection. |
| Secondary | Proportion of Participants With Normalized TSH Throughout the Maintenance Period | Day 29 of the Maintenance Period | Proportion of participants enrolled with normalized TSH throughout the Maintenance Period |
| Secondary | Proportion of Participants With Normalized TSH at End of Maintenance Period | Day 29 of the Maintenance Period | Proportion of participants enrolled with normalized TSH at the end of the Maintenance Period. |
| Secondary | Thyroid Hormone Concentrations: Total Thyroxine | Up to Day 29 of the Maintenance Period | Thyroid hormone concentrations (total thyroxine, free protein-unbound thyroxine (fT4), and TSH) following the first dose of XP-8121 during the Titration Period and Maintenance Periods |
| Secondary | Thyroid Hormone Concentrations: Free Thyroxine (fT4) | Up to Day 29 of the Maintenance Period | Thyroid hormone concentrations (total thyroxine, free protein-unbound thyroxine (fT4), and TSH) following the first dose of XP-8121 during the Titration Period and Maintenance Periods |
| Secondary | Thyroid Hormone Concentrations: Thyroid Stimulating Hormone (TSH) | Up to Day 29 of the Maintenance Period | Thyroid hormone concentrations (total thyroxine, free protein-unbound thyroxine (fT4), and TSH) following the first dose of XP-8121 during the Titration Period and Maintenance Periods |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose Conversion Factor | Day 29 of the Maintenance Period | The Completer Population used for this analysis is defined as all participants who completed the Maintenance Period and exhibited normalized TSH throughout the Maintenance Period while on a stable dose of XP-8121 for approximately 6 weeks. Participants with a reduced dose at any point during the Maintenance Period were not included in the Completer Population. | Ratio | GEOMETRIC_LEAST_SQUARES_MEAN |
| PRIMARY | Tolerability Assessment: Modified Draize Scale - Erythema | Week 1 Dosing in Titration Period through Day 22 Dosing in Maintenance Period | The number of participants at each timepoint is dependent on the number of participants dosed at each timepoint. The number of participants decreases in association with study withdrawal, with the exception of the reduction in the number of participants in Titration Periods Week 7 and Week 8 due to the number of participants that transitioned to the Maintenance Period after dosing at Week 6. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Tolerability Assessment: Modified Draize Scale - Edema | Week 1 Dosing in Titration Period through Day 22 Dosing in Maintenance Period | The number of participants at each timepoint is dependent on the number of participants dosed at each timepoint. The number of participants decreases in association with study withdrawal, with the exception of the reduction in the number of participants in Titration Periods Week 7 and Week 8 due to the number of participants that transitioned to the Maintenance Period after dosing at Week 6. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Tolerability Assessments: Injection Site Discomfort Evaluation | Week 1 dosing in the Titration Period through Day 22 dosing in the Maintenance Period | The number of participants at each timepoint is dependent on the number of participants dosed at each timepoint. The number of participants decreases in association with study withdrawal, with the exception of the reduction in the number of participants in Titration Periods Week 7 and Week 8 due to the number of participants that transitioned to the Maintenance Period after dosing at Week 6. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants With Normalized TSH Throughout the Maintenance Period | Day 29 of the Maintenance Period | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Participants With Normalized TSH at End of Maintenance Period | Day 29 of the Maintenance Period | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Thyroid Hormone Concentrations: Total Thyroxine | Up to Day 29 of the Maintenance Period | The number of participants at each timepoint is dependent on the number of participants dosed at each timepoint. The overall number follows the decrease associated with study withdrawal, with the exception of the reduction in the number of participants in Titration Periods Week 7 and Week 8 due to the number of participants that transitioned to the Maintenance Period after dosing at Week 6. | nmol/L | MEAN |
| SECONDARY | Thyroid Hormone Concentrations: Free Thyroxine (fT4) | Up to Day 29 of the Maintenance Period | The number of participants at each timepoint is dependent on the number of participants dosed at each timepoint. The overall number follows the decrease associated with study withdrawal, with the exception of the reduction in the number of participants in Titration Periods Week 7 and Week 8 due to the number of participants that transitioned to the Maintenance Period after dosing at Week 6. | pmol/L | MEAN |
| SECONDARY | Thyroid Hormone Concentrations: Thyroid Stimulating Hormone (TSH) | Up to Day 29 of the Maintenance Period | The number of participants at each timepoint is dependent on the number of participants dosed at each timepoint. The overall number follows the decrease associated with study withdrawal, with the exception of the reduction in the number of participants in Titration Periods Week 7 and Week 8 due to the number of participants that transitioned to the Maintenance Period after dosing at Week 6. | mIU/L | MEAN |
Source ClinicalTrials.gov
Results by group188
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose Conversion Factor | XP-8121 | 4.24 | 90% Confidence Interval 4.06 to 4.42 | Ratio | |
| Tolerability Assessment: Modified Draize Scale - Erythema | XP-8121 | Titration Period: Week 1 Dosing / 0 - None | 43 | Participants | |
| Tolerability Assessment: Modified Draize Scale - Erythema | XP-8121 | Titration Period: Week 1 Dosing / 1 - Very Slight | 3 | Participants | |
| Tolerability Assessment: Modified Draize Scale - Erythema | XP-8121 | Titration Period: Week 1 Dosing / 2 - Slight | 0 | Participants | |
| Tolerability Assessment: Modified Draize Scale - Erythema | XP-8121 | Titration Period: Week 1 Dosing / 3 - Moderate | 0 | Participants | |
| Tolerability Assessment: Modified Draize Scale - Erythema | XP-8121 | Titration Period: Week 1 Dosing / 4 - Severe | 0 | Participants | |
| Tolerability Assessment: Modified Draize Scale - Erythema | XP-8121 | Titration Period: Week 2 Dosing / 0 - None | 41 | Participants | |
| Tolerability Assessment: Modified Draize Scale - Erythema | XP-8121 | Titration Period: Week 2 Dosing / 1 - Very Slight | 2 | Participants | |
| Tolerability Assessment: Modified Draize Scale - Erythema | XP-8121 | Titration Period: Week 2 Dosing / 2 - Slight | 0 | Participants | |
| Tolerability Assessment: Modified Draize Scale - Erythema | XP-8121 | Titration Period: Week 2 Dosing / 3 - Moderate | 0 | Participants |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Titration Period | STARTED | XP-8121 | 46 | |
| Titration Period | COMPLETED | XP-8121 | 42 | |
| Titration Period | NOT COMPLETED | XP-8121 | 4 | |
| Maintenance Period | STARTED | XP-8121 | 42 | |
| Maintenance Period | COMPLETED | XP-8121 | 39 | |
| Maintenance Period | NOT COMPLETED | XP-8121 | 3 |
Source ClinicalTrials.gov
Adverse events27
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 | Fatigue | General disorders | Titration Period | 10 | 46 | 12 |
| other | Fatigue | General disorders | Maintenance Period | 0 | 42 | 0 |
| other | Fatigue | General disorders | Overall | 10 | 46 | 12 |
| other | Injection site pain | General disorders | Titration Period | 3 | 46 | 4 |
| other | Injection site pain | General disorders | Maintenance Period | 2 | 42 | 2 |
| other | Injection site pain | General disorders | Overall | 5 | 46 | 6 |
| other | Temperature intolerance | General disorders | Titration Period | 2 | 46 | 3 |
| other | Temperature intolerance | General disorders | Maintenance Period | 0 | 42 | 0 |
| other | Temperature intolerance | General disorders | Overall | 2 | 46 | 3 |
| other | Urinary tract infection | Infections and infestations | Titration Period | 3 | 46 | 3 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Titration Period | 0 | 46 |
| Total, all-cause mortality | Maintenance Period | 0 | 42 |
| Total, all-cause mortality | Overall | 0 | 46 |
| Total, other adverse events | Titration Period | 19 | 46 |
| Total, other adverse events | Maintenance Period | 4 | 42 |
| Total, other adverse events | Overall | 22 | 46 |
| Total, serious adverse events | Titration Period | 0 | 46 |
| Total, serious adverse events | Maintenance Period | 0 | 42 |
| Total, serious adverse events | Overall | 0 | 46 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| All Participants vs Participants Who Entered Maintenance Period: Proportion of Participants With Normalized TSH at End of Maintenance Period | Trial comparisons |
| All Participants vs Participants Who Entered the Maintenance Period: Proportion of Participants With Normalized TSH Throughout the Maintenance Period | 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/NCT05823012
GET https://conductscience.org/api/trials/v1/NCT05823012/results?page=2