A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects

Browse trials for

• Overweight 3,670
• Body Weight 1,223

Keywords

• overweight
• obesity
• pramlintide
• Symlin
• sibutramine
• Meridia
• phentermine
• Amylin

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 258 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Study arms

• Experimental
  1

  Drug: pramlintide acetate

• Experimental
  2

  Drug: pramlintide acetate · Drug: sibutramine

• Experimental
  3

  Drug: pramlintide acetate · Drug: phentermine

• Placebo comparator
  4

  Drug: placebo

Interventions

• Drugpramlintide acetate

  subcutaneous injection, three times a day, 120mcg

  Also known as: Symlin

• Drugsibutramine

  oral tablet, once a day, 10mg

  Also known as: Meridia

• Drugphentermine

  oral tablet, once a day, 37.5mg

  Also known as: Adipex-P, Fastin, Obenix, Oby-Trim

• Drugplacebo

  subcutaneous injection, three times a day

Primary outcomes

1. All treatment-emergent adverse events occurring during the 24-week treatment period

   Time frame: 24 weeks

2. Absolute change in body weight from baseline to Week 12

   Time frame: 12 weeks

Secondary outcomes

1. Percent change in body weight from baseline to Week 12

   Time frame: 12 weeks

2. Percentage of subjects achieving at least 5% weight loss from baseline to Week 12 and Week 24

   Time frame: 24 weeks

3. Absolute and percent changes in body weight from baseline to Week 2, Week 4, Week 8, Week 16, Week 20, and Week 24

   Time frame: 24 weeks

4. Absolute changes in anthropometric measurements (hip and waist circumferences) from baseline to Week 12 and Week 24

   Time frame: 24 weeks

5. Changes in fasting serum concentrations of lipids from baseline to Week 12 and Week 24

   Time frame: 24 weeks

6. Changes in summary measures derived from patient reported outcome questionnaires from baseline to Week 12 and Week 24

   Time frame: 24 weeks

7. Changes in individual item responses from patient reported outcome questionnaires from baseline to Week 12 and Week 24

   Time frame: 24 weeks