Table 1.
A Summary of the Clinical Trials Dedicated in Clinical Impact of Semaglutide on Obesity Management
Author (Year)Ref. | Setting | Aim | n | Outcomes | Limitations | Study Design |
---|---|---|---|---|---|---|
Enebo et al (2021)39 | Single center of Altasciences Clinical Kansas in Kansas, USA | To study the safety, tolerability, pharmacokinetics, and pharmacodynamics of cagrilintide in combination with semaglutide | 96 (18–55 years) | - MBW percentage reductions were greater in case of the combination of cagrilintide and semaglutide 2·4 mg (over 15%) as compared to placebo (about 10%) | - Relatively shorter duration of study (20 weeks) and the treatment time at final target dose was also short (4 weeks) - Primarily worked on safety and tolerability of the combination of drugs, so weight loss outcomes have to be interpreted with caution. |
Phase Ib |
Blundell et al (2017)44 | Single center study conducted in UK | To assess the activity of semaglutide in comparison with placebo in relation to body weight and energy intake | 30 (18 years or older) | - Reduction in MBW by about 5 kg, but placebo group showed an increase in body weight by about 1 kg | - Lower number of participants in the study - Relatively shorter duration of study (12 weeks) |
Phase I |
Friedrichsen et al (2021)45 | Germany | To assess the efficacy of semaglutide 2.4 mg once weekly administration on appetite, gastric emptying, and energy intake | 72 (18 to 65 years) | - MBW decreased by about 9.9% with semaglutide administration, while with placebo body weight reduced by about 0.4% - Semaglutide group experienced significantly lower level of hunger and higher level of fullness (all p < 0.02) |
The use of paracetamol as approach to assessing gastric emptying | Phase I |
Wilding et al (2021)53 | 129 sites in 16 countries | To assess the efficacy and safety of semaglutide 2.4mg once weekly administration for 68-weeks | 1961 (18 years or older) | - MBW reduction (−14.9%) as compared to placebo (−2.4%, p < 0.001) | - Relatively shorter duration of study (12 weeks) and higher number of female participant | Phase III |
Rubino et al (2021)54 | 73 sites in 10 countries | To assess the efficacy of semaglutide 2.4mg once weekly administration for 20-weeks on weight maintenance | 902 (18 years or older) | - MBW reduction (−7.9%) as compared to placebo (+6.9%, p < 0.001) - Waist circumference, physical functioning, and SBP improved significantly with continuous semaglutide administration as compared to placebo (all p < 0.001) |
- The run-in period was inflexible limiting the outcomes only to patients tolerating the drug outcomes | Phase IIIa |
Bækdal et al (2018)55 | Multicenter | To assess the effect of hepatic impairment on the pharmacokinetics, tolerability, and safety of oral semaglutide | 56 (18–85 years) | Once-daily oral administration with 5 mg of drug for first five days and then 10 mg of drug for the next five days did not apparently affected the pharmacokinetics, safety, and tolerability of the drug in patients with hepatic impairment | - Open-label design and short study duration. - Number of participants in the groups was low and was not equal to each other |
Phase I |
Abbreviation: MBW, Mean Body weight.