What is a Phase 3 Clinical Trial?

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Phase 3 clinical trials follow phase 1 and 2 clinical trials. In a phase 1 clinical trial, the tolerability and safety of the new drug is studied, usually in a small number of healthy volunteers. Phase 2 is aimed at determining the drug's efficacy and optimal dosing regimen. After phase 2, the drug is entered into the next phase of testing in a phase 3 trial.

The main focus of phase 3 trials is to demonstrate and confirm the prelimary evidence gathered in the previous trials that the drug is, a safe, beneficial and effective treatment for the intended indication.

Phase 3 is the last phase of testing to be completed before the drug's details and clinical trial results are submitted to the regulatory authorities for approval of the drug's release on the open market. Phase 3 is therefore a vital phase of drug development and billions may be spent progressing the drug to a phase 3 trial, only for the drug to prove ineffective in a larger patient population or have serious safety concerns that prevent its approval.

Phase 3 trials are often multicentre trials involving up to 3,000 participants. Aside from testing safety and efficacy variables again, other aspects of the drug that may be studied in phase 3 are further exploration of the dose-response relationship, the drug's effects in wider populations and its efficacy at different stages of disease or when used in combination with other agents.

The drug may also be tested in subgroups with co-morbidities such as kidney or liver disease or heart disorders. Much of the information that is given on the label of a drug is derived from the phase 3 trial results.

Other factors that may be considered inphase 3 include improvement in patients' quality of life and secondary benefits of the drug.

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Key takeaways

The mazdutide study (GLORY-1 Phase 3 trial) demonstrated 20.6% mean body weight loss at 48 weeks on the 6mg weekly dose. Matching tirzepatide's efficacy in two-thirds the trial duration.
Mazdutide's dual GLP-1/glucagon receptor mechanism increases resting energy expenditure by 15% at 24 weeks, a thermogenic effect not observed with pure GLP-1 agonists like semaglutide.
HbA1c reductions of 1.1 percentage points in prediabetic participants exceeded those seen with tirzepatide (0.94 points) or semaglutide (0.78 points) in comparable populations.
Gastrointestinal adverse events occurred in 38% of mazdutide participants. Slightly lower than tirzepatide (42%) or semaglutide (44%) despite comparable weight loss magnitude.
The mazdutide study showed a respiratory quotient decrease from 0.85 to 0.78, indicating a metabolic shift from carbohydrate to fat oxidation as the primary fuel source.
Waist circumference reductions averaged 13.7 cm, correlating with 34% decreases in hsCRP and significant improvements in lipid panels (22% LDL reduction, 28% triglyceride reduction).

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01A Real Step Forward?

The FDA has accepted AbbVie’s new drug application for tavapadon in PD and the company remains on track for FDA action later this year, Zadikoff told Medscape Medical News . The co-authors of a linked Comment wrote that the TEMPO-2 findings “clearly confirm” that selective D1 receptor stimulation improves motor symptoms in early PD. “Adding a D1 agonist into the panel of available dopaminergic antiparkinsonian medications has been long awaited. Tavapadon could fill this gap,” wrote Olivier Rascol, MD, PhD, and Margherita Fabbri, MD, from University Hospital of Toulouse in Toulouse, France. They noted, however, that the TEMPO-2 trial does not answer some key questions that are “mandatory” to anticipate the future positioning of tavapadon among other antiparkinsonian dopaminergic options in clinical practice, especially D2 agonists and levodopa. “This missing evidence is due to the absence of an active comparator in the trial, its limited sample size, and a short follow-up,” they wrote. They also noted the relatively high treatment discontinuation rate in the TEMPO-2 trial and said larger, longer-term comparative studies will be needed to fully define the drug’s benefit-risk profile and place in therapy. “Time will tell,” they concluded, whether tavapadon represents “a real step forward” over existing dopamine agonists or simply “a ‘me too’ drug.” The study was funded by AbbVie. Disclosures for the authors are available with the original study publication. Rascol disclosed having relationships with Bial, Biogen, Britannia, Cerevel, Contera, GE Healthcare, Ionis, Jazz, Kyowa, LGD Nuvamid, Lundbeck, Merz, NeuraLight, NeurATRIS, Neuroderm, Orion Pharma, Parexel, Roche Therapeutics, Sanofi, Thelonius Mind, Teva, UCB, and Zambon. Fabbri disclosed having relationships with AbbVie, BIAL, Medtronic, Orkyn, Ever Pharma, Teitur Trophics, and Zambon.

Source: www.medscape.com ↗

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