LIFT Study: A Safety, Tolerability, Efficacy, and Pharmac... | NCT04328077

Status Module

Label	Type	Description	Intervention Names
TERN-101 dose level 1	Experimental	Orally administered.	Drug: TERN-101
TERN-101 dose level 2	Experimental	Orally administered.	Drug: TERN-101
TERN-101 dose level 3	Experimental	Orally administered.	Drug: TERN-101
Placebo	Placebo Comparator	Orally administered.	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
TERN-101	Drug	Investigational drug	TERN-101 dose level 1 TERN-101 dose level 2 TERN-101 dose level 3

Measure	Description	Time Frame
Number of Participants With Adverse Events for TERN-101 Versus Placebo		16 weeks

Measure	Description	Time Frame
Percent Change From Baseline in ALT Outcome Measure		12 weeks
Plasma Concentration of TERN-101 - AUC 0-24	Area under the curve	12 weeks (0-24 hours post dose)

Eligibility Module

Name	Affiliation	Role
clinicaltrials@ternspharma.com	Terns, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Terns Clinical Study Site 1017		Chandler	Arizona	85224	United States
Terns Clinical Study Site 1018

ID	Title	Description
FG000	Placebo	Placebo Comparator: Placebo: Orally administered
FG001	TERN-101 5mg	Experimental: TERN-101 dose level 1: Orally administered

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 22, 2020	May 6, 2022

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00050.4± 11.00 BG00148.0± 12.32 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00016 BG00115 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG00021 BG00123 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG00020 BG00117 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00026 BG00125 BG002

ALT

Baseline ALT (U/L) was defined as the average of all assessments prior to dosing.

Mean

Standard Deviation

U/L

Title

Denominators

Categories

Title	Measurements
	BG00055.51± 23.639 BG00156.25± 16.266

Diabetes Mellitus Status

Diabetes Mellitus status was defined as having reported any medical history MedDRA preferred term including "Diabetes mellitus" or "Diabetic neuropathy" or "Diabetic retinopathy".

Count of Participants

Participants

Title

Denominators

Categories

Absent

Title	Measurements
	BG00015 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Adverse Events for TERN-101 Versus Placebo

Safety Population: All patients who received at least 1 dose of study drug

Posted

Count of Participants

Participants

16 weeks

ID	Title	Description
OG000	Placebo	Placebo Comparator: Placebo: Orally administered
OG001	TERN-101 5 mg	Experimental: TERN-101 dose level 1: Orally administered
OG002	TERN-101 10 mg	Experimental: TERN-101 dose level 2: Orally administered
OG003	TERN-101 15 mg	Experimental: TERN-101 dose level 3: Orally administered

Units	Counts
Participants	OG00026 OG00125 OG00226 OG003

Title

Denominators

Categories

Title	Measurements
	OG00010 OG00113 OG00214 OG003

Secondary

Percent Change From Baseline in ALT Outcome Measure

Efficacy Population: All randomized patients who received at least 1 dose of study drug

Posted

Least Squares Mean

Standard Error

percentage of change from baseline

12 weeks

ID	Title	Description
OG000	Placebo	Placebo Comparator: Placebo: Orally administered
OG001	TERN-101 5 mg	Experimental: TERN-101 dose level 1: Orally administered
OG002	TERN-101 10 mg	Experimental: TERN-101 dose level 2: Orally administered
OG003	TERN-101 15 mg	Experimental: TERN-101 dose level 3: Orally administered

Units	Counts
Participants

Secondary

Plasma Concentration of TERN-101 - AUC 0-24

Area under the curve

All randomized patients in the PK/PD substudy who received at least 1 dose of TERN-101. The minimum requirement for the calculation of AUC required: A minimum of 3 measurable concentration-time-points during the log-linear portion of the terminal elimination phase (after tmax), excluding Cmax; r²adj ≥ 0.80 for the regression of the log-concentration time data during the terminal elimination phase; Negative slope for log regression fit.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

12 weeks (0-24 hours post dose)

ID	Title	Description
OG000	TERN-101 5mg	Experimental: TERN-101 dose level 1: Orally administered
OG001	TERN-101 10mg	Experimental: TERN-101 dose level 2: Orally administered
OG002	TERN-101 15mg	Experimental: TERN-101 dose level 3: Orally administered

Units	Counts

Secondary

Plasma Concentration of TERN-101 - Cmax

Maximum observed concentration

All randomized patients in the PK/PD substudy who received at least 1 dose of TERN-101.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

12 Weeks (0-72 hours post dose)

ID	Title	Description
OG000	TERN-101 5 mg	Experimental: TERN-101 dose level 1: Orally administered
OG001	TERN-101 10 mg	Experimental: TERN-101 dose level 2: Orally administered
OG002	TERN-101 15 mg	Experimental: TERN-101 dose level 3: Orally administered

Units	Counts
Participants	OG000

Secondary

Plasma Concentration of TERN-101 - Tmax

Time to reach maximum measured plasma concentration

All randomized patients in the PK/PD substudy who received at least 1 dose of TERN-101.

Posted

Median

Full Range

hour

12 Weeks (0-72 hours post dose)

ID	Title	Description
OG000	TERN-101 5 mg	Experimental: TERN-101 dose level 1: Orally administered
OG001	TERN-101 10 mg	Experimental: TERN-101 dose level 2: Orally administered
OG002	TERN-101 15 mg	Experimental: TERN-101 dose level 3: Orally administered

Units	Counts
Participants	OG000

Secondary

Plasma Concentration of TERN-101 - t1/2

Determination of half-life

All randomized patients in the PK/PD substudy who received at least 1 dose of TERN-101. The minimum requirement for the calculation of t1/2 required: A minimum of 3 measurable concentration-time-points during the log-linear portion of the terminal elimination phase (after Tmax), excluding Cmax; r²adj ≥ 0.80 for the regression of the log-concentration time data during the terminal elimination phase; and negative slope for log regression fit.

Posted

Median

Full Range

hour

12 Weeks (0-72 hours post dose)

ID	Title	Description
OG000	TERN-101 5 mg	Experimental: TERN-101 dose level 1: Orally administered
OG001	TERN-101 10 mg	Experimental: TERN-101 dose level 2: Orally administered
OG002	TERN-101 15 mg	Experimental: TERN-101 dose level 3: Orally administered

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0013 events3 affected25 at risk EG0023 events3 affected26 at risk EG0034 events4 affected23 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0002 events2 affected26 at risk EG0011 events1 affected25 at risk EG0023 events3 affected26 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected26 at risk EG0011 events1 affected25 at risk EG0021 events1 affected26 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0022 events2 affected26 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Dizziness	Nervous system disorders	Systematic Assessment	EG0001 events1 affected26 at risk EG0011 events1 affected25 at risk EG0022 events2 affected26 at risk EG003
COVID-19	Infections and infestations	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0021 events1 affected26 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected26 at risk EG0011 events1 affected25 at risk EG0021 events1 affected26 at risk EG003
Anxiety	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Asymptomatic COVID-19	Infections and infestations	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected26 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected26 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected26 at risk EG003
Tooth infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0021 events1 affected26 at risk EG003
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected26 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Asthenia	General disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Blood glucose increased	Investigations	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected26 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
COVID-19 pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Conjunctivitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Early satiety	General disorders	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected26 at risk EG003
Faecaloma	General disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Flatulence	General disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected26 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected26 at risk EG003
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected26 at risk EG003
Hepatic enzyme increased	Investigations	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Hypertension	Vascular disorders	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Influenza	Infections and infestations	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Influenza like illness	General disorders	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Injection site pain	General disorders	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Insomnia	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected26 at risk EG003
Lethargy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected26 at risk EG003
Magnetic resonance imaging abnormal	Investigations	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected26 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected26 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected26 at risk EG003
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Oedema peripheral	General disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected26 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected26 at risk EG003
Panic attack	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected26 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Soft tissue infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Tooth abscess	Infections and infestations	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected26 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected26 at risk EG003
Toothache	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected26 at risk EG003
Trigger finger	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected26 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected26 at risk EG003
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected26 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Vision blurred	Eye disorders	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected26 at risk EG003
Weight increased	Investigations	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected26 at risk EG003

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

ID	Title	Description
BG000	Placebo	Placebo Comparator: Placebo: Orally administered
BG001	TERN-101 5mg	Experimental: TERN-101 dose level 1: Orally administered
BG002	TERN-101 10mg	Experimental: TERN-101 dose level 2: Orally administered
BG003	TERN-101 15mg	Experimental: TERN-101 dose level 3: Orally administered
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo Comparator: Placebo: Orally administered	26	1	26	10	26
EG001	TERN-101 5mg	Experimental: TERN-101 dose level 1: Orally administered	25	0	25	13	25
EG002	TERN-101 10mg	Experimental: TERN-101 dose level 2: Orally administered	26	0	26	14	26
EG003	TERN-101 15mg	Experimental: TERN-101 dose level 3: Orally administered	23	1	23	15	23