Trial Outcomes & Findings for A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH (NCT NCT04006145)

NCT ID: NCT04006145

Last Updated: 2026-02-05

Results Overview

The primary efficacy endpoint was the change from Baseline in serum LDL-C at Week 16. Baseline was defined as the last non-missing LDL-C value prior to the first dose of study drug.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 47 participants
• Primary outcome timeframe: Week 16
• Results posted on: 2026-02-05

Participant Flow

This double-blind, randomized, placebo-controlled, phase 2 study was conducted at 15 sites in the United States to explore the efficacy and safety of elobixibat (oral dose of 5 milligrams [mg]) once daily for 16 weeks in participants with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH).

The study consisted of a 6-week screening period followed by a 16-week treatment period and a follow-up visit 2 weeks after the last dose of study drug.

Participant milestones

Measure	Placebo Placebo Placebo oral tablet: Placebo identical in appearance to active drug	Elobixibat Elobixibat 5 mg once daily Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).
Overall Study STARTED	24	23
Overall Study Received Treatment	24	23
Overall Study COMPLETED	21	22
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	Placebo Placebo Placebo oral tablet: Placebo identical in appearance to active drug	Elobixibat Elobixibat 5 mg once daily Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).
Overall Study Lost to Follow-up	1	0
Overall Study Other	2	1

Baseline Characteristics

One participant was counted under both NAFLD and NASH per case report form (CRF) collected data.

Baseline characteristics by cohort

Measure	Elobixibat n=23 Participants Elobixibat 5 mg once daily Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).	Placebo n=24 Participants Placebo Placebo oral tablet: Placebo identical in appearance to active drug	Total n=47 Participants Total of all reporting groups
Age, Continuous	51.8 years STANDARD_DEVIATION 10.77 • n=23 Participants	50.0 years STANDARD_DEVIATION 13.36 • n=24 Participants	50.9 years STANDARD_DEVIATION 12.07 • n=47 Participants
Sex: Female, Male Female	15 Participants n=23 Participants	16 Participants n=24 Participants	31 Participants n=47 Participants
Sex: Female, Male Male	8 Participants n=23 Participants	8 Participants n=24 Participants	16 Participants n=47 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=23 Participants	16 Participants n=24 Participants	32 Participants n=47 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=23 Participants	8 Participants n=24 Participants	15 Participants n=47 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=23 Participants	0 Participants n=24 Participants	0 Participants n=47 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=23 Participants	0 Participants n=24 Participants	0 Participants n=47 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=23 Participants	0 Participants n=24 Participants	3 Participants n=47 Participants
Race/Ethnicity, Customized Race · Black or African American	2 Participants n=23 Participants	2 Participants n=24 Participants	4 Participants n=47 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=23 Participants	0 Participants n=24 Participants	0 Participants n=47 Participants
Race/Ethnicity, Customized Race · White	18 Participants n=23 Participants	21 Participants n=24 Participants	39 Participants n=47 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=23 Participants	1 Participants n=24 Participants	1 Participants n=47 Participants
Region of Enrollment United States	23 participants n=23 Participants	24 participants n=24 Participants	47 participants n=47 Participants
Disease under study Nonalcoholic Fatty Liver Disease (NAFLD)	13 Participants n=23 Participants	13 Participants n=24 Participants	26 Participants n=47 Participants
Disease under study Nonalcoholic Steatohepatitis (NASH)	11 Participants n=23 Participants	11 Participants n=24 Participants	22 Participants n=47 Participants
Duration of disease (Years) Nonalcoholic Fatty Liver Disease (NAFLD)	1.879 years STANDARD_DEVIATION 2.667 • n=13 Participants • One participant was counted under both NAFLD and NASH per case report form (CRF) collected data.	1.534 years STANDARD_DEVIATION 2.908 • n=13 Participants • One participant was counted under both NAFLD and NASH per case report form (CRF) collected data.	1.707 years STANDARD_DEVIATION 2.739 • n=26 Participants • One participant was counted under both NAFLD and NASH per case report form (CRF) collected data.
Duration of disease (Years) Nonalcoholic Steatohepatitis (NASH)	1.610 years STANDARD_DEVIATION 2.918 • n=11 Participants • One participant was counted under both NAFLD and NASH per case report form (CRF) collected data.	0.892 years STANDARD_DEVIATION 1.246 • n=11 Participants • One participant was counted under both NAFLD and NASH per case report form (CRF) collected data.	1.251 years STANDARD_DEVIATION 2.220 • n=22 Participants • One participant was counted under both NAFLD and NASH per case report form (CRF) collected data.

PRIMARY outcome

Timeframe: Week 16

Population: The intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study drug.

The primary efficacy endpoint was the change from Baseline in serum LDL-C at Week 16. Baseline was defined as the last non-missing LDL-C value prior to the first dose of study drug.

Outcome measures

Measure	Elobixibat n=23 Participants Elobixibat 5 mg once daily Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).	Placebo n=24 Participants Placebo Placebo oral tablet: Placebo identical in appearance to active drug
Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at Week 16	-0.57 "mmol/L" Standard Error 0.125	-0.17 "mmol/L" Standard Error 0.134

SECONDARY outcome

Timeframe: From first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months

Population: The safety population included all participants who were randomized and received at least 1 dose of study drug.

An adverse event (AE) was any untoward medical occurrence in enrolled participant regardless of causal relationship with study drug. An SAE was defined as any AE that, at any dose, resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity, required or prolonged hospitalization, was a congenital anomaly/birth defect or an important medical event. TEAEs were defined as AEs that were new or worsened after the first dose of study drug.

Outcome measures

Measure	Elobixibat n=23 Participants Elobixibat 5 mg once daily Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).	Placebo n=24 Participants Placebo Placebo oral tablet: Placebo identical in appearance to active drug
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) TEAEs	13 Participants	10 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) TESAEs	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 16

Population: The ITT population included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 16 are reported.

The effect of elobixibat on liver steatosis was measured by magnetic resonance imaging (MRI) for liver fat fraction using proton density fat fraction [PDFF]). Baseline was defined as the last non-missing value prior to the first dose of study drug.

Outcome measures

Measure	Elobixibat n=21 Participants Elobixibat 5 mg once daily Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).	Placebo n=18 Participants Placebo Placebo oral tablet: Placebo identical in appearance to active drug
Absolute Change From Baseline to Week 16 in Liver Fat Fraction	-0.43 percent of liver fat Standard Error 1.203	0.09 percent of liver fat Standard Error 1.299

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 16

Population: The ITT population included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 16 are reported.

The effect of elobixibat on liver steatosis was measured by MRI for total liver fat using whole liver fat volume. Baseline was defined as the last non-missing value prior to the first dose of study drug.

Outcome measures

Measure	Elobixibat n=21 Participants Elobixibat 5 mg once daily Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).	Placebo n=18 Participants Placebo Placebo oral tablet: Placebo identical in appearance to active drug
Absolute Change From Baseline to Week 16 in Total Liver Fat	-2.80 milliliter Standard Error 36.240	7.95 milliliter Standard Error 39.146

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 16

Population: The ITT population included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 16 are reported.

Serum samples were collected at specified timepoints to assess ALT, AST and GGT levels. Baseline was defined as the last non-missing value prior to the first dose of study drug.

Outcome measures

Measure	Elobixibat n=22 Participants Elobixibat 5 mg once daily Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).	Placebo n=20 Participants Placebo Placebo oral tablet: Placebo identical in appearance to active drug
Change From Baseline to Week 16 in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl Transferase (GGT) ALT	5.04 Units/liter Standard Error 3.914	1.05 Units/liter Standard Error 3.969
Change From Baseline to Week 16 in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl Transferase (GGT) AST	2.21 Units/liter Standard Error 2.250	0.96 Units/liter Standard Error 2.359
Change From Baseline to Week 16 in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl Transferase (GGT) GGT	5.12 Units/liter Standard Error 2.009	-1.73 Units/liter Standard Error 2.108

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 16

Population: The ITT population included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 16 are reported.

Blood samples were collected at specified timepoints to assess HDL and non-HDL cholesterol levels and triglycerides. Baseline was defined as the last non-missing value prior to the first dose of study drug.

Outcome measures

Measure	Elobixibat n=22 Participants Elobixibat 5 mg once daily Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).	Placebo n=20 Participants Placebo Placebo oral tablet: Placebo identical in appearance to active drug
Change From Baseline to Week 16 in High-density Lipoprotein (HDL) Cholesterol, Non-high-density Lipoprotein Cholesterol and Triglycerides HDL cholesterol	0.03 millimoles/liter Standard Error 0.047	-0.05 millimoles/liter Standard Error 0.049
Change From Baseline to Week 16 in High-density Lipoprotein (HDL) Cholesterol, Non-high-density Lipoprotein Cholesterol and Triglycerides Non-HDL cholesterol	-0.75 millimoles/liter Standard Error 0.154	-0.23 millimoles/liter Standard Error 0.162
Change From Baseline to Week 16 in High-density Lipoprotein (HDL) Cholesterol, Non-high-density Lipoprotein Cholesterol and Triglycerides Triglycerides	-0.13 millimoles/liter Standard Error 0.149	-0.08 millimoles/liter Standard Error 0.156

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 16

Population: The ITT population included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 16 are reported.

Blood samples were collected at specified timepoints to assess LDL and HDL cholesterol levels and ratio was obtained. Baseline was defined as the last non-missing value prior to the first dose of study drug.

Outcome measures

Measure	Elobixibat n=22 Participants Elobixibat 5 mg once daily Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).	Placebo n=20 Participants Placebo Placebo oral tablet: Placebo identical in appearance to active drug
Change From Baseline to Week 16 in Low-density Lipoprotein (LDL) Cholesterol to High-density Lipoprotein Cholesterol Ratio	-0.56 ratio Standard Error 0.158	-0.11 ratio Standard Error 0.166

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 16

Population: The ITT population included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 16 are reported.

Blood samples were collected at specified timepoints to assess total bile acid levels. Baseline was defined as the last non-missing value prior to the first dose of study drug.

Outcome measures

Measure	Elobixibat n=22 Participants Elobixibat 5 mg once daily Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).	Placebo n=20 Participants Placebo Placebo oral tablet: Placebo identical in appearance to active drug
Change From Baseline to Week 16 in Total Bile Acids	0.49 micromoles/liter Standard Error 0.696	0.33 micromoles/liter Standard Error 0.714

Adverse Events

Elobixibat

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Elobixibat n=23 participants at risk Elobixibat 5 mg once daily Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).	Placebo n=24 participants at risk Placebo Placebo oral tablet: Placebo identical in appearance to active drug
Gastrointestinal disorders Diarrhoea	21.7% 5/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	0.00% 0/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Gastrointestinal disorders Nausea	0.00% 0/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	8.3% 2/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Gastrointestinal disorders Abdominal pain	0.00% 0/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	4.2% 1/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Gastrointestinal disorders Vomiting	0.00% 0/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	4.2% 1/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Infections and infestations Bacterial abdominal infection	4.3% 1/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	0.00% 0/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Infections and infestations Hordeolum	4.3% 1/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	0.00% 0/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Infections and infestations Tooth infection	4.3% 1/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	0.00% 0/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Infections and infestations Diarrhoea infectious	0.00% 0/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	4.2% 1/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Infections and infestations Ear infection	0.00% 0/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	4.2% 1/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Infections and infestations Nasopharyngitis	0.00% 0/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	4.2% 1/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Infections and infestations Urinary tract infection	0.00% 0/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	4.2% 1/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Infections and infestations Vaginal infection	0.00% 0/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	4.2% 1/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Nervous system disorders Dizziness	4.3% 1/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	4.2% 1/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Nervous system disorders Headache	4.3% 1/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	0.00% 0/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Nervous system disorders Paraesthesia	0.00% 0/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	4.2% 1/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Metabolism and nutrition disorders Hyperglycaemia	4.3% 1/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	0.00% 0/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	4.2% 1/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Tooth fracture	4.3% 1/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	0.00% 0/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Investigations Blood triglycerides increased	4.3% 1/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	0.00% 0/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Vascular disorders Hypertension	4.3% 1/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	0.00% 0/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	4.2% 1/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	4.2% 1/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	4.2% 1/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Ear and labyrinth disorders Vertigo	0.00% 0/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	4.2% 1/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
General disorders Non-cardiac chest pain	0.00% 0/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	4.2% 1/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Renal and urinary disorders Renal pain	0.00% 0/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	4.2% 1/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	4.2% 1/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/23 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.	4.2% 1/24 • Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months Analysis was performed on the safety analysis set.

Additional Information

Patrick Horn, MD, PhD

Albireo AB

Phone: +1 (857) 378- 2035

Email: medinfo@albireopharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee Albireo will retain the ownership of all data. All proposed publications based on this study must be subject to the sponsor's approval requirements.
• Publication restrictions are in place

Restriction type: OTHER