Assessment cycle 2023 Q1 — page 3
Documents ratified in the 2023 Q1 assessment cycle, which ran from 1 January 2023 to 31 March 2023 and was ratified on 18 March 2023.
Documents ratified
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Randomised, double-blind, placebo-controlled, phase 2b study of AOD-9604 in obesity randomising 536 participants over 12 weeks. Primary result: No separation from…
05 Aug 2023 -
Randomised, double-blind, placebo-controlled, phase 2 study of AOD-9604 in knee osteoarthritis over 12 weeks. Primary result: No consistent benefit demonstrated.
Low18 Feb 2024 -
Randomised, double-blind, placebo-controlled, phase 2 study of Thymosin beta-4 in wound healing randomising 72 participants over 4 weeks. Primary result: Improvement in…
Low12 Dec 2023 -
Randomised, double-blind, placebo-controlled, phase 2 study of Thymosin beta-4 in wound healing randomising 72 participants over 84 days. Primary result: A signal in a…
Low18 Dec 2023 -
Randomised, double-blind, placebo-controlled, phase 2 study of Thymosin beta-4 in wound healing randomising 30 participants over 12 weeks. Primary result: No significant…
Low19 Sep 2023 -
Phase 1 ascending dose, phase 1 study of Thymosin beta-4 in cardiovascular over single and multiple dose. Primary result: Tolerated over the doses evaluated; no efficacy…
Very low09 Nov 2023 -
Randomised, double-blind, placebo-controlled, phase 1/2 study of LL-37 in wound healing randomising 34 participants over 4 weeks. Primary result: A dose-dependent…
Low21 Nov 2023 -
Randomised, double-blind, placebo-controlled, phase 2 study of GHK-Cu in wound healing over 12 weeks. Primary result: Improvement in skin appearance measures in…
Low18 Oct 2023 -
Randomised, double-blind, placebo-controlled, phase 2 study of GHK-Cu in wound healing over 12 weeks. Primary result: Directionally consistent with the companion study…
Low02 May 2024 -
Randomised, double-blind, active-controlled, phase 3 study of Thymosin alpha-1 in immune modulation over 52 weeks. Primary result: A modest effect relative to interferon…
Moderate22 May 2024 -
Randomised, double-blind, active-controlled, phase 3 study of Thymosin alpha-1 in immune modulation over 48 weeks. Primary result: An adjunctive effect in combination…
Moderate03 Jun 2023 -
Randomised, double-blind, placebo-controlled, phase 3 study of Thymosin alpha-1 in immune modulation randomising 361 participants over 28 days. Primary result: A…
Moderate09 Jan 2024 -
Randomised, double-blind, placebo-controlled, phase 2 study of Thymosin alpha-1 in immune modulation over 8 weeks. Primary result: Higher antibody titres reported…
Moderate30 Apr 2023 -
Randomised, double-blind, placebo-controlled, phase 2 study of Glutathione in cognition randomising 45 participants over 3 months. Primary result: No significant…
Low01 Jan 2024 -
Randomised, double-blind, placebo-controlled, phase 2b study of Larazotide acetate in mucosal barrier randomising 342 participants over 12 weeks. Primary result: A…
Moderate09 Feb 2024 -
Randomised, double-blind, placebo-controlled, phase 3 study of Larazotide acetate in mucosal barrier over 12 weeks. Primary result: Terminated at a pre-planned interim…
01 Jun 2023 -
Randomised crossover, phase 2 study of SS-31 (elamipretide) in mitochondrial disease randomising 30 participants over 4 weeks per period. Primary result: An increase in…
Moderate03 Mar 2024 -
Randomised, double-blind, placebo-controlled, phase 3 study of SS-31 (elamipretide) in mitochondrial disease randomising 218 participants over 24 weeks. Primary result…
Moderate02 Feb 2024 -
Randomised, double-blind, placebo-controlled, phase 3 study of PT-141 (bremelanotide) in sexual dysfunction randomising 626 participants over 24 weeks. Primary result: A…
Moderate21 Oct 2023 -
Randomised, double-blind, placebo-controlled, phase 3 study of PT-141 (bremelanotide) in sexual dysfunction randomising 630 participants over 24 weeks. Primary result…
Moderate05 Oct 2023 -
Randomised, double-blind, placebo-controlled, phase 3 study of Teduglutide in mucosal barrier randomising 86 participants over 24 weeks. Primary result: Response in 63 %…
Moderate14 Oct 2023 -
Single-arm open-label, phase 3 study of Teduglutide in mucosal barrier randomising 88 participants over 24 months. Primary result: Reductions were maintained during…
Moderate11 Sep 2023 -
Diagnostic accuracy, phase 1 study of Kisspeptin-10 in gh axis over single test. Primary result: A reproducible luteinising-hormone response used as a research probe of…
Low05 Feb 2024 -
Single-arm open-label, phase 2 study of Kisspeptin-10 in gh axis randomising 60 participants over single cycle. Primary result: Maturation achieved with a lower reported…
Low22 Sep 2023 -
Randomised crossover, phase 2 study of Kisspeptin-10 in sexual dysfunction randomising 32 participants over single administration per period. Primary result: A change in…
Low09 Nov 2023 -
Randomised, double-blind, placebo-controlled, phase 3 study of Pramlintide in type 1 diabetes (adjunct) randomising 480 participants over 52 weeks. Primary result: A…
Moderate01 May 2023 -
Randomised, double-blind, placebo-controlled, phase 3 study of Pramlintide in type 2 diabetes randomising 656 participants over 52 weeks. Primary result: A modest…
Moderate24 Dec 2023 -
Randomised, double-blind, placebo-controlled, phase 2 study of Pramlintide in obesity randomising 411 participants over 16 weeks. Primary result: A weight reduction of…
Low27 Apr 2024 -
Randomised, double-blind, placebo-controlled, phase 2 study of SS-31 (elamipretide) in hfpef randomising 71 participants over 4 weeks. Primary result: No significant…
Low22 Mar 2024 -
Single-arm open-label, phase 3 study of Teduglutide in mucosal barrier randomising 59 participants over 24 weeks. Primary result: A reduction in parenteral support…
Moderate13 Dec 2023 -
Observational, phase 3 study of Semaglutide in obesity over as stated in the parent protocol. The Institute holds no reported primary result for this record and…
Very low04 Jul 2023 -
Randomised crossover, phase 1 study of Semaglutide in obesity and type 2 diabetes over as stated in the parent protocol. The Institute holds no reported primary result…
Very low01 Jun 2023 -
Randomised, double-blind, placebo-controlled, phase 3 study of Semaglutide in obesity over as stated in the parent protocol. The Institute holds no reported primary…
Very low18 Dec 2023 -
Phase 1 ascending dose, phase 1 study of Semaglutide in obesity over as stated in the parent protocol. The Institute holds no reported primary result for this record and…
Very low20 May 2023 -
Phase 1 ascending dose, phase 1 study of Semaglutide in obesity and prediabetes over as stated in the parent protocol. The Institute holds no reported primary result for…
Very low12 Jun 2023 -
Phase 1 ascending dose, phase 1 study of Semaglutide in obesity over as stated in the parent protocol. The Institute holds no reported primary result for this record and…
Very low22 Jun 2023 -
Phase 1 ascending dose, phase 1 study of Semaglutide in adolescent obesity over as stated in the parent protocol. The Institute holds no reported primary result for this…
Very low09 Nov 2023 -
Phase 1 ascending dose, phase 1 study of Semaglutide in hfpef and obesity over as stated in the parent protocol. The Institute holds no reported primary result for this…
Very low28 Dec 2023 -
Randomised, double-blind, placebo-controlled, phase 3 study of Semaglutide in type 2 diabetes over as stated in the parent protocol. The Institute holds no reported…
Very low27 Jul 2023 -
Randomised, double-blind, placebo-controlled, phase 3 study of Semaglutide in cardiovascular and type 2 diabetes over as stated in the parent protocol. The Institute…
Very low29 Feb 2024
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