Trial Outcomes & Findings for A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants (NCT NCT04124705)
NCT ID: NCT04124705
Last Updated: 2024-06-05
Results Overview
Sustained TSH response is defined as TSH values that are within the normal reference range of 0.45 to 4.12 mIU/L, inclusive, at both the end of Titration Period and the end of the Stabilization Period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
284 participants
Primary outcome timeframe
End of the titration period (Week 18, 24, 30, or 36) and end of the stabilization period (Week 30, 36, 42, or 48, depending on the length of the titration period).
Results posted on
2024-06-05
Participant Flow
This study enrolled adults with a diagnosis of primary hypothyroidism who were taking a stable daily dose of synthetic T4 hormone (levothyroxine). Participants were enrolled at 27 sites in the United States.
Eligible participants were randomized equally to receive either their same dose of levothyroxine or a matching dose of Armour Thyroid at Baseline. The randomization was stratified by age (\< 65 years, ≥ 65 years).
Participant milestones
| Measure |
Armour® Thyroid
Participants were randomized to receive Armour Thyroid at a dose corresponding to their pre-randomized dose of synthetic T4. During the first 18 to 36 weeks (titration period) the dose of Armour Thyroid could be titrated based on levels of thyroid stimulating hormone (TSH), in order to achieve TSH levels within the normal reference range (0.45 - 4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of Armour Thyroid for an additional 12 weeks (stabilization period).
|
Levothyroxine
Participants were randomized to receive levothyroxine at their pre-randomized dose. During the first 18 to 36 weeks (titration period) the dose of levothyroxine could be titrated based on levels of TSH in order to achieve TSH levels within the normal reference range (0.45-4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of levothyroxine for an additional 12 weeks (stabilization period).
|
|---|---|---|
|
Titration Period
STARTED
|
141
|
143
|
|
Titration Period
Received Study Treatment
|
141
|
143
|
|
Titration Period
COMPLETED
|
115
|
124
|
|
Titration Period
NOT COMPLETED
|
26
|
19
|
|
Stabilization Period
STARTED
|
115
|
124
|
|
Stabilization Period
COMPLETED
|
104
|
114
|
|
Stabilization Period
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
| Measure |
Armour® Thyroid
Participants were randomized to receive Armour Thyroid at a dose corresponding to their pre-randomized dose of synthetic T4. During the first 18 to 36 weeks (titration period) the dose of Armour Thyroid could be titrated based on levels of thyroid stimulating hormone (TSH), in order to achieve TSH levels within the normal reference range (0.45 - 4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of Armour Thyroid for an additional 12 weeks (stabilization period).
|
Levothyroxine
Participants were randomized to receive levothyroxine at their pre-randomized dose. During the first 18 to 36 weeks (titration period) the dose of levothyroxine could be titrated based on levels of TSH in order to achieve TSH levels within the normal reference range (0.45-4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of levothyroxine for an additional 12 weeks (stabilization period).
|
|---|---|---|
|
Titration Period
Adverse Event
|
9
|
5
|
|
Titration Period
Withdrawal by Subject
|
6
|
3
|
|
Titration Period
Lost to Follow-up
|
0
|
1
|
|
Titration Period
Death
|
1
|
1
|
|
Titration Period
Lack of Efficacy
|
2
|
0
|
|
Titration Period
Physician Decision
|
2
|
0
|
|
Titration Period
Non-compliance with Study Drug
|
2
|
0
|
|
Titration Period
Other
|
4
|
9
|
|
Stabilization Period
Adverse Event
|
4
|
2
|
|
Stabilization Period
Withdrawal by Subject
|
1
|
1
|
|
Stabilization Period
Lost to Follow-up
|
0
|
1
|
|
Stabilization Period
Lack of Efficacy
|
4
|
2
|
|
Stabilization Period
Protocol Deviation
|
0
|
2
|
|
Stabilization Period
Other
|
2
|
2
|
Baseline Characteristics
A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants
Baseline characteristics by cohort
| Measure |
Armour® Thyroid
n=141 Participants
Participants were randomized to receive Armour Thyroid at a dose corresponding to their pre-randomized dose of synthetic T4. During the first 18 to 36 weeks (titration period) the dose of Armour Thyroid could be titrated based on levels of TSH, in order to achieve TSH levels within the normal reference range (0.45 - 4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of Armour Thyroid for an additional 12 weeks (stabilization period).
|
Levothyroxine
n=143 Participants
Participants were randomized to receive levothyroxine at their pre-randomized dose. During the first 18 to 36 weeks (titration period) the dose of levothyroxine could be titrated based on levels of TSH in order to achieve TSH levels within the normal reference range (0.45-4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of levothyroxine for an additional 12 weeks (stabilization period).
|
Total
n=284 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 12.94 • n=5 Participants
|
53.4 years
STANDARD_DEVIATION 13.97 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 13.45 • n=5 Participants
|
|
Age, Customized
< 65 years
|
108 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
234 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
124 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
124 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Thyroid Stimulating Hormone (TSH) Level
|
1.81 mIU/L
STANDARD_DEVIATION 1.175 • n=5 Participants
|
2.08 mIU/L
STANDARD_DEVIATION 1.507 • n=7 Participants
|
1.95 mIU/L
STANDARD_DEVIATION 1.357 • n=5 Participants
|
PRIMARY outcome
Timeframe: End of the titration period (Week 18, 24, 30, or 36) and end of the stabilization period (Week 30, 36, 42, or 48, depending on the length of the titration period).Population: All randomized participants who took at least 1 dose of study intervention (intent-to-treat population). The non-responder imputation incorporating multiple imputation to handle missing data due to coronavirus disease 2019 (COVID-19) (NRI-C) was performed for participants who had missing TSH values either at the end of the Titration Period or at the end of the Stabilization Period.
Sustained TSH response is defined as TSH values that are within the normal reference range of 0.45 to 4.12 mIU/L, inclusive, at both the end of Titration Period and the end of the Stabilization Period.
Outcome measures
| Measure |
Armour® Thyroid
n=141 Participants
Participants were randomized to receive Armour Thyroid at a dose corresponding to their pre-randomized dose of synthetic T4. During the first 18 to 36 weeks (titration period) the dose of Armour Thyroid could be titrated based on levels of TSH, in order to achieve TSH levels within the normal reference range (0.45 - 4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of Armour Thyroid for an additional 12 weeks (stabilization period).
|
Levothyroxine
n=143 Participants
Participants were randomized to receive levothyroxine at their pre-randomized dose. During the first 18 to 36 weeks (titration period) the dose of levothyroxine could be titrated based on levels of TSH in order to achieve TSH levels within the normal reference range (0.45-4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of levothyroxine for an additional 12 weeks (stabilization period).
|
|---|---|---|
|
Percentage of Participants With a Sustained TSH Response
|
60.76 percentage of participants
Interval 52.6 to 68.92
|
75.92 percentage of participants
Interval 68.65 to 83.19
|
SECONDARY outcome
Timeframe: End of the titration period (Week 18, 24, 30, or 36)Population: All randomized participants who took at least 1 dose of study intervention (intent-to-treat population). The non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was performed for participants who had missing TSH values at the end of Titration Period.
Titration TSH Response is defined as having a TSH value within the normal reference range of 0.45 to 4.12 mIU/L, inclusive, at the end of the Titration Period.
Outcome measures
| Measure |
Armour® Thyroid
n=141 Participants
Participants were randomized to receive Armour Thyroid at a dose corresponding to their pre-randomized dose of synthetic T4. During the first 18 to 36 weeks (titration period) the dose of Armour Thyroid could be titrated based on levels of TSH, in order to achieve TSH levels within the normal reference range (0.45 - 4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of Armour Thyroid for an additional 12 weeks (stabilization period).
|
Levothyroxine
n=143 Participants
Participants were randomized to receive levothyroxine at their pre-randomized dose. During the first 18 to 36 weeks (titration period) the dose of levothyroxine could be titrated based on levels of TSH in order to achieve TSH levels within the normal reference range (0.45-4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of levothyroxine for an additional 12 weeks (stabilization period).
|
|---|---|---|
|
Percentage of Participants With a Titration TSH Response
|
80.62 percentage of participants
Interval 74.05 to 87.18
|
91.13 percentage of participants
Interval 86.35 to 95.92
|
Adverse Events
Armour® Thyroid
Serious events: 4 serious events
Other events: 15 other events
Deaths: 1 deaths
Levothyroxine
Serious events: 7 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Armour® Thyroid
n=141 participants at risk
Participants were randomized to receive Armour Thyroid at a dose corresponding to their pre-randomized dose of synthetic T4. During the first 18 to 36 weeks (titration period) the dose of Armour Thyroid could be titrated based on levels of TSH, in order to achieve TSH levels within the normal reference range (0.45 - 4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of Armour Thyroid for an additional 12 weeks (stabilization period).
|
Levothyroxine
n=143 participants at risk
Participants were randomized to receive levothyroxine at their pre-randomized dose. During the first 18 to 36 weeks (titration period) the dose of levothyroxine could be titrated based on levels of TSH in order to achieve TSH levels within the normal reference range (0.45-4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of levothyroxine for an additional 12 weeks (stabilization period).
|
|---|---|---|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.00%
0/141 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
0.70%
1/143 • Number of events 1 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.71%
1/141 • Number of events 1 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
0.00%
0/143 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.71%
1/141 • Number of events 1 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
0.00%
0/143 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.71%
1/141 • Number of events 1 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
0.00%
0/143 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
|
Infections and infestations
COVID-19
|
0.00%
0/141 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
0.70%
1/143 • Number of events 1 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
|
Infections and infestations
OTITIS MEDIA
|
0.71%
1/141 • Number of events 1 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
0.00%
0/143 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
|
Infections and infestations
PUNCTURE SITE ABSCESS
|
0.00%
0/141 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
0.70%
1/143 • Number of events 1 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
|
Infections and infestations
SEPSIS
|
1.4%
2/141 • Number of events 2 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
0.00%
0/143 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.00%
0/141 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
0.70%
1/143 • Number of events 1 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/141 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
0.70%
1/143 • Number of events 1 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
|
Nervous system disorders
MIGRAINE WITH AURA
|
0.00%
0/141 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
0.70%
1/143 • Number of events 1 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
|
Nervous system disorders
SEIZURE
|
0.71%
1/141 • Number of events 1 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
0.00%
0/143 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
|
Renal and urinary disorders
URETEROLITHIASIS
|
0.00%
0/141 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
0.70%
1/143 • Number of events 1 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
|
Reproductive system and breast disorders
ADNEXA UTERI CYST
|
0.00%
0/141 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
0.70%
1/143 • Number of events 1 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
Other adverse events
| Measure |
Armour® Thyroid
n=141 participants at risk
Participants were randomized to receive Armour Thyroid at a dose corresponding to their pre-randomized dose of synthetic T4. During the first 18 to 36 weeks (titration period) the dose of Armour Thyroid could be titrated based on levels of TSH, in order to achieve TSH levels within the normal reference range (0.45 - 4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of Armour Thyroid for an additional 12 weeks (stabilization period).
|
Levothyroxine
n=143 participants at risk
Participants were randomized to receive levothyroxine at their pre-randomized dose. During the first 18 to 36 weeks (titration period) the dose of levothyroxine could be titrated based on levels of TSH in order to achieve TSH levels within the normal reference range (0.45-4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of levothyroxine for an additional 12 weeks (stabilization period).
|
|---|---|---|
|
General disorders
FATIGUE
|
5.0%
7/141 • Number of events 7 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
5.6%
8/143 • Number of events 8 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
|
Psychiatric disorders
ANXIETY
|
5.7%
8/141 • Number of events 8 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
0.70%
1/143 • Number of events 1 • From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER