Skip to content

Study · Randomized controlled trial · n = 270 · 2008

10 results

Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity.

Smith SR, Aronne LJ, Burns CM, Kesty NC, Halseth AE, Weyer C

Diabetes care20 Jun 2008Cited by 135 (Europe PMC)

PMID18753666 (opens in a new tab)PMCIDPMC2518351 (opens in a new tab)DOI10.2337/dc08-0029 (opens in a new tab)PepBankPUB-18753666
Read at sourcePubMedAsk about this study
Jump to 10 results

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In obese subjects receiving lifestyle intervention, weight loss across pramlintide arms ranged from 3.8 to 6.1 kg versus 2.8 kg with placebo.

    In plain wordsIn obese subjects receiving lifestyle intervention, weight loss ranged higher with pramlintide than placebo.

    Peptide
    Pramlintide (Symlin)
    Outcome
    DecreaseWeight loss at month 4 across doses
    Study

    n = 270

    Comparator
    Placebo with lifestyle intervention
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    120, 240, or 360 microg b.i.d. or t.i.d. · 4 monthsAs given in this study (human).

    Measurements

    Weight loss
    3.8 to 6.1 kg
    pramlintide arms
    Weight loss
    2.8 kg
    placebo

    Source sentences

    Summary
    At month 4, mean weight loss from baseline in the pramlintide arms ranged from 3.8 +/- 0.7 to 6.1 +/- 0.8 kg (2.8 +/- 0.8 kg with placebo).
    2 context sentences
    Summary · context
    In a 4-month, double-blind, placebo-controlled, dose-ranging study, 411 obese subjects were randomized to receive pramlintide (six arms: 120, 240, and 360 microg b.i.d. and t.i.d.) or placebo in conjunction with a structured LSI program geared toward weight loss.
    Summary · context
    Of the 4-month evaluable subjects (n = 270), 77% opted to continue preexisting treatment during an 8-month single-blind extension (LSI geared toward weight maintenance).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In obese subjects, initial weight loss was maintained in all pramlintide groups except 120 microg b.i.d., while placebo subjects regained weight.

    In plain wordsIn obese subjects, most pramlintide groups maintained weight loss, while placebo subjects regained weight.

    Peptide
    Pramlintide (Symlin)
    Outcome
    MixedWeight loss maintenance at month 12
    Study

    n = 146

    Comparator
    Placebo with lifestyle intervention
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    120, 240, or 360 microg b.i.d. or t.i.d. · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    By month 12, initial 4-month weight loss was regained in the placebo group but was maintained in all but the 120-microg b.i.d. group.
    2 context sentences
    Summary · context
    In a 4-month, double-blind, placebo-controlled, dose-ranging study, 411 obese subjects were randomized to receive pramlintide (six arms: 120, 240, and 360 microg b.i.d. and t.i.d.) or placebo in conjunction with a structured LSI program geared toward weight loss.
    Summary · context
    Of the 4-month evaluable subjects (n = 270), 77% opted to continue preexisting treatment during an 8-month single-blind extension (LSI geared toward weight maintenance).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In obese subjects, pramlintide 120 microg t.i.d. produced placebo-corrected weight loss of 3.2 kg at month 4.

    In plain wordsIn obese subjects, pramlintide 120 microg three times daily reduced weight more than placebo at month 4.

    Peptide
    Pramlintide (Symlin)
    Outcome
    DecreaseWeight loss at month 4 with 120 microg t.i.d.
    Study

    n: not reported in source

    Comparator
    Placebo with lifestyle intervention
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    120 microg t.i.d. · 4 monthsAs given in this study (human).

    Measurements

    Placebo-corrected weight loss
    3.2 kg
    120 microg t.i.d., month 4
    Placebo-corrected weight loss
    3.1%
    120 microg t.i.d., month 4

    Source sentences

    Summary
    Placebo-corrected weight loss with 120 microg t.i.d. and 360 microg b.i.d. averaged 3.2 +/- 1.2 kg (3.1 +/- 1.1% body wt) and 3.3 +/- 1.1 kg (3.1 +/- 1.0% body wt), respectively, at month 4
    2 context sentences
    Summary · context
    In a 4-month, double-blind, placebo-controlled, dose-ranging study, 411 obese subjects were randomized to receive pramlintide (six arms: 120, 240, and 360 microg b.i.d. and t.i.d.) or placebo in conjunction with a structured LSI program geared toward weight loss.
    Summary · context
    Of the 4-month evaluable subjects (n = 270), 77% opted to continue preexisting treatment during an 8-month single-blind extension (LSI geared toward weight maintenance).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In obese subjects, pramlintide 360 microg b.i.d. produced placebo-corrected weight loss of 3.3 kg at month 4.

    In plain wordsIn obese subjects, pramlintide 360 microg twice daily reduced weight more than placebo at month 4.

    Peptide
    Pramlintide (Symlin)
    Outcome
    DecreaseWeight loss at month 4 with 360 microg b.i.d.
    Study

    n: not reported in source

    Comparator
    Placebo with lifestyle intervention
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    360 microg b.i.d. · 4 monthsAs given in this study (human).

    Measurements

    Placebo-corrected weight loss
    3.3 kg
    360 microg b.i.d., month 4
    Placebo-corrected weight loss
    3.1%
    360 microg b.i.d., month 4

    Source sentences

    Summary
    Placebo-corrected weight loss with 120 microg t.i.d. and 360 microg b.i.d. averaged 3.2 +/- 1.2 kg (3.1 +/- 1.1% body wt) and 3.3 +/- 1.1 kg (3.1 +/- 1.0% body wt), respectively, at month 4
    2 context sentences
    Summary · context
    In a 4-month, double-blind, placebo-controlled, dose-ranging study, 411 obese subjects were randomized to receive pramlintide (six arms: 120, 240, and 360 microg b.i.d. and t.i.d.) or placebo in conjunction with a structured LSI program geared toward weight loss.
    Summary · context
    Of the 4-month evaluable subjects (n = 270), 77% opted to continue preexisting treatment during an 8-month single-blind extension (LSI geared toward weight maintenance).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In obese subjects, pramlintide 120 microg t.i.d. produced placebo-corrected weight loss of 6.1 kg at month 12.

    In plain wordsIn obese subjects, pramlintide 120 microg three times daily reduced weight more than placebo at month 12.

    Peptide
    Pramlintide (Symlin)
    Outcome
    DecreaseWeight loss at month 12 with 120 microg t.i.d.
    Study

    n: not reported in source

    Comparator
    Placebo with lifestyle intervention
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    120 microg t.i.d. · 12 monthsAs given in this study (human).

    Measurements

    Placebo-corrected weight loss
    6.1 kg
    120 microg t.i.d., month 12
    Placebo-corrected weight loss
    5.6%
    120 microg t.i.d., month 12

    Source sentences

    Summary
    and 6.1 +/- 2.1 kg (5.6 +/- 2.1% body wt) and 7.2 +/- 2.3 kg (6.8 +/- 2.3% body wt), respectively, at month 12 (both P < 0.01; 12-month evaluable n = 146).
    3 context sentences
    Summary · context
    Placebo-corrected weight loss with 120 microg t.i.d. and 360 microg b.i.d. averaged 3.2 +/- 1.2 kg (3.1 +/- 1.1% body wt) and 3.3 +/- 1.1 kg (3.1 +/- 1.0% body wt), respectively, at month 4
    Summary · context
    In a 4-month, double-blind, placebo-controlled, dose-ranging study, 411 obese subjects were randomized to receive pramlintide (six arms: 120, 240, and 360 microg b.i.d. and t.i.d.) or placebo in conjunction with a structured LSI program geared toward weight loss.
    Summary · context
    Of the 4-month evaluable subjects (n = 270), 77% opted to continue preexisting treatment during an 8-month single-blind extension (LSI geared toward weight maintenance).
  6. 06HumanRandomized controlled trialEfficacy outcome

    In obese subjects, pramlintide 360 microg b.i.d. produced placebo-corrected weight loss of 7.2 kg at month 12.

    In plain wordsIn obese subjects, pramlintide 360 microg twice daily reduced weight more than placebo at month 12.

    Peptide
    Pramlintide (Symlin)
    Outcome
    DecreaseWeight loss at month 12 with 360 microg b.i.d.
    Study

    n: not reported in source

    Comparator
    Placebo with lifestyle intervention
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    360 microg b.i.d. · 12 monthsAs given in this study (human).

    Measurements

    Placebo-corrected weight loss
    7.2 kg
    360 microg b.i.d., month 12
    Placebo-corrected weight loss
    6.8%
    360 microg b.i.d., month 12

    Source sentences

    Summary
    and 6.1 +/- 2.1 kg (5.6 +/- 2.1% body wt) and 7.2 +/- 2.3 kg (6.8 +/- 2.3% body wt), respectively, at month 12 (both P < 0.01; 12-month evaluable n = 146).
    3 context sentences
    Summary · context
    Placebo-corrected weight loss with 120 microg t.i.d. and 360 microg b.i.d. averaged 3.2 +/- 1.2 kg (3.1 +/- 1.1% body wt) and 3.3 +/- 1.1 kg (3.1 +/- 1.0% body wt), respectively, at month 4
    Summary · context
    In a 4-month, double-blind, placebo-controlled, dose-ranging study, 411 obese subjects were randomized to receive pramlintide (six arms: 120, 240, and 360 microg b.i.d. and t.i.d.) or placebo in conjunction with a structured LSI program geared toward weight loss.
    Summary · context
    Of the 4-month evaluable subjects (n = 270), 77% opted to continue preexisting treatment during an 8-month single-blind extension (LSI geared toward weight maintenance).
  7. 07HumanRandomized controlled trialEfficacy outcome

    In obese subjects, 40% with pramlintide 120 microg t.i.d. achieved at least 10% weight loss versus 12% with placebo.

    In plain wordsIn obese subjects, major weight loss was more common with pramlintide 120 microg three times daily than placebo.

    Peptide
    Pramlintide (Symlin)
    Outcome
    IncreaseAt least 10% weight loss with 120 microg t.i.d.
    Study

    n: not reported in source

    Comparator
    Placebo with lifestyle intervention
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    120 microg t.i.d. · 12 monthsAs given in this study (human).

    Measurements

    Weight loss responders
    40%
    120 microg t.i.d., at least 10% weight loss
    Weight loss responders
    12%
    placebo, at least 10% weight loss

    Source sentences

    Summary
    At month 12, 40 and 43% of subjects treated with 120 microg t.i.d. and 360 microg b.i.d., respectively, achieved >or=10% weight loss (vs. 12% for placebo).
    2 context sentences
    Summary · context
    In a 4-month, double-blind, placebo-controlled, dose-ranging study, 411 obese subjects were randomized to receive pramlintide (six arms: 120, 240, and 360 microg b.i.d. and t.i.d.) or placebo in conjunction with a structured LSI program geared toward weight loss.
    Summary · context
    Of the 4-month evaluable subjects (n = 270), 77% opted to continue preexisting treatment during an 8-month single-blind extension (LSI geared toward weight maintenance).
  8. 08HumanRandomized controlled trialEfficacy outcome

    In obese subjects, 43% with pramlintide 360 microg b.i.d. achieved at least 10% weight loss versus 12% with placebo.

    In plain wordsIn obese subjects, major weight loss was more common with pramlintide 360 microg twice daily than placebo.

    Peptide
    Pramlintide (Symlin)
    Outcome
    IncreaseAt least 10% weight loss with 360 microg b.i.d.
    Study

    n: not reported in source

    Comparator
    Placebo with lifestyle intervention
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    360 microg b.i.d. · 12 monthsAs given in this study (human).

    Measurements

    Weight loss responders
    43%
    360 microg b.i.d., at least 10% weight loss
    Weight loss responders
    12%
    placebo, at least 10% weight loss

    Source sentences

    Summary
    At month 12, 40 and 43% of subjects treated with 120 microg t.i.d. and 360 microg b.i.d., respectively, achieved >or=10% weight loss (vs. 12% for placebo).
    2 context sentences
    Summary · context
    In a 4-month, double-blind, placebo-controlled, dose-ranging study, 411 obese subjects were randomized to receive pramlintide (six arms: 120, 240, and 360 microg b.i.d. and t.i.d.) or placebo in conjunction with a structured LSI program geared toward weight loss.
    Summary · context
    Of the 4-month evaluable subjects (n = 270), 77% opted to continue preexisting treatment during an 8-month single-blind extension (LSI geared toward weight maintenance).
  9. 09HumanRandomized controlled trialSafety outcome

    In obese subjects, nausea occurred in 9-29% of pramlintide recipients versus 2% with placebo and was generally mild to moderate.

    In plain wordsIn obese subjects, nausea was more common with pramlintide than placebo and was generally mild to moderate.

    Peptide
    Pramlintide (Symlin)
    Outcome
    IncreaseNausea during initial study
    Study

    n: not reported in source

    Comparator
    Placebo with lifestyle intervention
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    120, 240, or 360 microg b.i.d. or t.i.d. · 4 monthsAs given in this study (human).

    Measurements

    Nausea
    9 to 29%
    pramlintide, initial study
    Nausea
    2%
    placebo

    Source sentences

    Summary
    Nausea, the most common adverse event with pramlintide in the 4-month study (9-29% pramlintide vs. 2% placebo), was generally mild to moderate and occurred in <10% of subjects during the extension.
    2 context sentences
    Summary · context
    In a 4-month, double-blind, placebo-controlled, dose-ranging study, 411 obese subjects were randomized to receive pramlintide (six arms: 120, 240, and 360 microg b.i.d. and t.i.d.) or placebo in conjunction with a structured LSI program geared toward weight loss.
    Summary · context
    Of the 4-month evaluable subjects (n = 270), 77% opted to continue preexisting treatment during an 8-month single-blind extension (LSI geared toward weight maintenance).
  10. 10HumanRandomized controlled trialSafety outcome

    In obese subjects, nausea occurred in fewer than 10% of subjects during the 8-month extension.

    In plain wordsIn obese subjects, fewer than 10% reported nausea during the extension.

    Peptide
    Pramlintide (Symlin)
    Outcome
    Not applicableNausea during extension
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 8-month extensionAs given in this study (human).

    Measurements

    Nausea
    < 10%
    extension

    Source sentences

    Summary
    Nausea, the most common adverse event with pramlintide in the 4-month study (9-29% pramlintide vs. 2% placebo), was generally mild to moderate and occurred in <10% of subjects during the extension.
    2 context sentences
    Summary · context
    In a 4-month, double-blind, placebo-controlled, dose-ranging study, 411 obese subjects were randomized to receive pramlintide (six arms: 120, 240, and 360 microg b.i.d. and t.i.d.) or placebo in conjunction with a structured LSI program geared toward weight loss.
    Summary · context
    Of the 4-month evaluable subjects (n = 270), 77% opted to continue preexisting treatment during an 8-month single-blind extension (LSI geared toward weight maintenance).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT00189514

A Study to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

AstraZenecan = 210Sept 2005 to Jun 2007

Obesity

Trial pageClinicalTrials.govUpdated 11 Jun 2015
CompletedPhase 2NCT00112021

A Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

AstraZenecan = 400May 2005 to Nov 2005

Obesity

Trial pageClinicalTrials.govUpdated 10 Apr 2015

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.