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ACE-031 clinical trials

ClinicalTrials.gov lists 4 registered trials of ACE-031: 0 recruiting or about to, 0 running, 2 completed, 1 with results posted. The largest is A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women (70 people).

4registered trials

0recruiting now

0running

2completed

0in phase 3

1with results posted

Completed: 2Stopped or withdrawn: 24trials
  • Completed 2
  • Stopped or withdrawn 2

Where ACE-031 is in testing

Registered trials by phase. Phase 3 trials are the large ones that decide approval.

0Early phase 1First doses in people
2Phase 1Safety and dosing
2Phase 2Does it work?
0Phase 3Large confirmatory trials
0Phase 4After approval
0Not phasedObservational and other

Timeline

Each bar runs from a trial's start to its planned end; faded bars have no end date. Click a bar to open the trial.

2008201020122014201620182020202220242026Extension Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy · Stopped or withdrawn · Phase 2 · 11 people · 2010-10 to 2011-05Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy · Stopped or withdrawn · Phase 2 · 24 people · 2010-04 to 2011-06A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women · Completed · Phase 1 · 70 people · 2009-08 to 2011-02A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal Volunteers · Completed · Phase 1 · 48 people · 2008-09 to 2009-07
RecruitingRunningCompletedStopped or withdrawnStatus unknownToday

Completed 2

A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women

CompletedPhase 170 peopleRandomizedAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA2009-08 → 2011-02🇨🇦 Canada

Studying: Muscular Atrophy · NCT00952887

About this trial

The purpose of this study is to establish safe dose levels of ACE-031 in healthy postmenopausal women following multiple dose administration. This study will also evaluate if ACE-031 has an effect on muscle.

A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal Volunteers

CompletedPhase 148 peopleRandomizedAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA2008-09 → 2009-07🇨🇦 Canada

Studying: Muscle Loss · NCT00755638

About this trial

Single center, randomized, single dose study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of ACE-031 in healthy postmenopausal volunteers

Stopped early or withdrawn 2

Extension Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy

TerminatedPhase 211 peopleAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA2010-10 → 2011-05🇨🇦 Canada

Studying: Duchenne Muscular Dystrophy · NCT01239758

About this trial

To evaluate the long-term safety and tolerability of ACE-031 administration in subjects with Duchenne muscular dystrophy (DMD) who participated in Study A031-03. \[Note: This study was terminated based on preliminary safety data. Pending further analysis of safety data and discussion with health authorities, a new ACE-031 trial will be planned.\]

Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy

TerminatedPhase 224 peopleRandomizedAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA2010-04 → 2011-06🇨🇦 CanadaResults posted

Studying: Duchenne Muscular Dystrophy · NCT01099761

About this trial

The purpose of this study is to determine if ACE-031 is safe and well-tolerated in boys with Duchenne Muscular Dystrophy (DMD) and to select the optimal doses of ACE-031 in terms of safety and pharmacodynamic (PD) activity for designing future studies. \[Note: This study was terminated based on safety data\]

Registered trials include ones that haven't published results yet. Trials are matched on the compound's name and code names (ACE-031, ActRIIB-Fc, ramatercept) in the listed interventions.