Adults 40 to 85, any sex, with Peripheral Artery Disease (PAD); Intermittent Claudication. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse Events (AEs), Drug-related AEs, Serious Adverse Events (SAEs) and DeathsPrimary· Up to 32 Weeks
An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign, including abnormal laboratory findings, symptom or disease) in a participant after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. An SAE is defined as any AE which is is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect in offspring, requires inpatient hos
Group
Value
95% CI
LLG783 6mg/kg
18
Placebo
17
LLG783 6mg/kg
4
Placebo
4
LLG783 6mg/kg
1
Placebo
2
LLG783 6mg/kg
0
Placebo
0
Change From Baseline in Maximum Walking Distance (MWD) as Assessed by 6-minute Walk Test (6MWT) at Week 16Primary· Baseline, Week 16 (Day 113)
MWD was assessed by the 6MWT prior to dosing was used to evaluate functional capacity of peripheral artery disease (PAD) participants. 6MWT test included measurement of total distance walked in 6 minutes.
Group
Value
95% CI
LLG783 6mg/kg
19.10
5.30 – 32.90
Placebo
36.84
21.99 – 51.70
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf)Secondary· 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
AUCinf is defined as the area under the serum concentration-time curve from time zero to infinity.
Day 1
Group
Value
95% CI
LLG783 6 mg/kg
2110
± 21.1
Day 85
Group
Value
95% CI
LLG783 6 mg/kg
4860
± 39.1
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)Secondary· 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
AUClast is defined as the area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration.
Day 1
Group
Value
95% CI
LLG783 6 mg/kg
1660
± 33.6
Day 85
Group
Value
95% CI
LLG783 6 mg/kg
4930
± 38.9
Area Under the Serum Concentration-time Curve From Time Zero to Defined Time Point 't' (AUC[0-t])Secondary· 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
AUC(0-t)is defined as the area under the serum concentration-time curve from time zero to time 't' where is a defined time point after administration.
Day 1
Group
Value
95% CI
LLG783 6 mg/kg
1640
± 34.1
Day 85
Group
Value
95% CI
LLG783 6 mg/kg
3130
± 34.7
Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)Secondary· 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
AUCtau is defined as the area under the serum concentration-time curve from time zero to the end of the dosing interval tau.
Day 1
Group
Value
95% CI
LLG783 6 mg/kg
1640
± 34.1
Day 85
Group
Value
95% CI
LLG783 6 mg/kg
3130
± 34.7
Observed Maximum Serum Concentration (Cmax) Following Drug AdministrationSecondary· 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
Cmax is defined as the observed maximum serum concentration following drug administration.
Day 1
Group
Value
95% CI
LLG783 6 mg/kg
203
± 40.0
Day 85
Group
Value
95% CI
LLG783 6 mg/kg
268
± 39.8
Time to Reach the Maximum Concentration After Drug Administration (Tmax)Secondary· 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
Tmax is defined as the time to reach the maximum concentration after drug administration.
Day 1
Group
Value
95% CI
LLG783 6 mg/kg
0.0833
0.0417 – 3.01
Day 85
Group
Value
95% CI
LLG783 6 mg/kg
0.0833
0.0431 – 9.94
Change From Baseline in Pain-free Walking Distance (PFWD) as Assessed by 6-minute Walk Test at Week 16Secondary· Baseline, Week 16 (Day 113)
PFWD was defined as the distance walked up to the point of onset of claudication symptoms (pain) recorded during the 6MWT and was used to evaluate symptomatic functional capacity of PAD participants. The PFWD was measured as the distance walked up to the time/place where the participant first experiences symptoms typical of their claudication which included pain, cramps, or other discomfort in the buttocks, thighs, calves or feet that occurs during the 6MWT exercise period.
Group
Value
95% CI
LLG783 6mg/kg
44.77
20.52 – 69.02
Placebo
57.09
30.97 – 83.22
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
LLG783 i.v. 6 mg/kg
Serious: 1/23 (4%)
Deaths: 0/23
Placebo
Serious: 2/23 (9%)
Deaths: 0/23
Serious adverse events (3 terms)
Reaction
System
LLG783 i.v. 6 mg/kg
Placebo
Hypochromic anaemia
Blood and lymphatic system disorders
—
—
Gastritis haemorrhagic
Gastrointestinal disorders
—
—
Small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This study is designed to determine whether LLG783 displays the clinical safety and efficacy profile, after multiple i.v. doses, to support further development in patients with PAD and intermittent claudication.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary
· Phase 3
· not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa
· Phase 4
· not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
· not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
· not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+
· Phase 1, PHASE2
· not yet recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 5 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03194776.