Progressive reduction in body weight after treatment with the amylin analog pramlintide in obese subjects: a phase 2, randomized, placebo-controlled, dose-escalation study.

Aronne L, Fujioka K, Aroda V, Chen K, Halseth A, Kesty NC, Burns C, Lush CW, Weyer C

The Journal of clinical endocrinology and metabolism15 May 2007Cited by 124 (Europe PMC)

PMID17504894DOI10.1210/jc.2006-2003PepBankPUB-17504894

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: Publisher copyright. Results still quote short attributed sentences.

Results from this study11

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

01HumanRandomized controlled trialSafety outcome
In obese subjects, withdrawal rates were similar with pramlintide and placebo.
In plain wordsIn obese subjects, withdrawals were similar with pramlintide and placebo.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeWithdrawal rate
Study
n = 204
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
Nonforced escalation to 240 microg three times daily · subcutaneous · 16 weeksAs given in this study (human).
Measurements
Withdrawals
29%
pramlintide
Withdrawals
25%
placebo
Source sentences
Summary
Withdrawal rates were similar between placebo (25%) and pramlintide-treated subjects (29%).
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study.
Summary · context
For 16 wk, without concomitant lifestyle intervention, subjects self-administered pramlintide (nonforced dose escalation < or = 240 microg) or placebo via sc injection three times a day before meals.
Report a problemFND-1750489402
02HumanRandomized controlled trialSafety outcome
In obese subjects receiving pramlintide, 88% could escalate to the maximum dose of 240 microg.
In plain wordsIn obese subjects receiving pramlintide, 88% could reach the maximum study dose.
Peptide
Pramlintide (Symlin)
Outcome
Not applicableEscalation to maximum dose
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Nonforced escalation to 240 microg three times daily · subcutaneous · 16 weeksAs given in this study (human).
Measurements
Maximum dose escalation
88%
pramlintide
Source sentences
Summary
Pramlintide was generally well tolerated, with 88% of subjects able to escalate to the maximum dose of 240 microg.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study.
Summary · context
For 16 wk, without concomitant lifestyle intervention, subjects self-administered pramlintide (nonforced dose escalation < or = 240 microg) or placebo via sc injection three times a day before meals.
Report a problemFND-1750489401
03HumanRandomized controlled trialEfficacy outcome
In obese subjects completing treatment, pramlintide produced placebo-corrected weight reductions of 3.7% and 3.6 kg.
In plain wordsIn obese subjects completing treatment, pramlintide reduced body weight more than placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseBody weight loss
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
Nonforced escalation to 240 microg three times daily · subcutaneous · 16 weeksAs given in this study (human).
Measurements
Placebo-corrected weight reduction
3.7%
completers
Placebo-corrected weight reduction
3.6 kg
completers
Source sentences
Summary
Subjects completing 16 wk of pramlintide treatment experienced placebo-corrected reductions in body weight of 3.7 +/- 0.5% (3.6 +/- 0.6 kg; P < 0.001) and waist circumference (3.6 +/- 1.1 cm; P < 0.01).
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study.
Summary · context
For 16 wk, without concomitant lifestyle intervention, subjects self-administered pramlintide (nonforced dose escalation < or = 240 microg) or placebo via sc injection three times a day before meals.
Report a problemFND-1750489403
04HumanRandomized controlled trialEfficacy outcome
In obese subjects completing treatment, pramlintide produced a placebo-corrected waist circumference reduction of 3.6 cm.
In plain wordsIn obese subjects completing treatment, pramlintide reduced waist size more than placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseWaist circumference
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
Nonforced escalation to 240 microg three times daily · subcutaneous · 16 weeksAs given in this study (human).
Measurements
Placebo-corrected waist reduction
3.6 cm
completers
Source sentences
Summary
Subjects completing 16 wk of pramlintide treatment experienced placebo-corrected reductions in body weight of 3.7 +/- 0.5% (3.6 +/- 0.6 kg; P < 0.001) and waist circumference (3.6 +/- 1.1 cm; P < 0.01).
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study.
Summary · context
For 16 wk, without concomitant lifestyle intervention, subjects self-administered pramlintide (nonforced dose escalation < or = 240 microg) or placebo via sc injection three times a day before meals.
Report a problemFND-1750489404
05HumanRandomized controlled trialEfficacy outcome
In obese subjects, approximately 31% with pramlintide achieved at least 5% weight loss versus 2% with placebo.
In plain wordsIn obese subjects, at least 5% weight loss was more common with pramlintide than placebo.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseAt least 5% weight loss
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
Nonforced escalation to 240 microg three times daily · subcutaneous · 16 weeksAs given in this study (human).
Measurements
Weight loss responders
≈ 31%
pramlintide, at least 5% loss
Weight loss responders
2%
placebo, at least 5% loss
Source sentences
Summary
Approximately 31% of pramlintide-treated subjects achieved > or =5% weight loss (vs. 2% placebo; P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study.
Summary · context
For 16 wk, without concomitant lifestyle intervention, subjects self-administered pramlintide (nonforced dose escalation < or = 240 microg) or placebo via sc injection three times a day before meals.
Report a problemFND-1750489405
06HumanRandomized controlled trialEfficacy outcome
In obese subjects, appetite control improvement was reported by 72% with pramlintide versus 31% with placebo.
In plain wordsIn obese subjects, improved appetite control was more common with pramlintide than placebo.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseReported appetite control improvement
Study
n: not reported in source
Comparator
Placebo
Outcome group
Appetite and food intake · Metabolic and weight
Studied dose
Nonforced escalation to 240 microg three times daily · subcutaneous · 16 weeksAs given in this study (human).
Measurements
Appetite control improvement
72%
pramlintide
Appetite control improvement
31%
placebo
Source sentences
Summary
More pramlintide than placebo-treated subjects reported improvements in appetite control (72% vs. 31%), weight control (63% vs. 24%), and overall well-being (52% vs. 17%).
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study.
Summary · context
For 16 wk, without concomitant lifestyle intervention, subjects self-administered pramlintide (nonforced dose escalation < or = 240 microg) or placebo via sc injection three times a day before meals.
Report a problemFND-1750489406
07HumanRandomized controlled trialEfficacy outcome
In obese subjects, weight control improvement was reported by 63% with pramlintide versus 24% with placebo.
In plain wordsIn obese subjects, improved weight control was more common with pramlintide than placebo.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseReported weight control improvement
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
Nonforced escalation to 240 microg three times daily · subcutaneous · 16 weeksAs given in this study (human).
Measurements
Weight control improvement
63%
pramlintide
Weight control improvement
24%
placebo
Source sentences
Summary
More pramlintide than placebo-treated subjects reported improvements in appetite control (72% vs. 31%), weight control (63% vs. 24%), and overall well-being (52% vs. 17%).
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study.
Summary · context
For 16 wk, without concomitant lifestyle intervention, subjects self-administered pramlintide (nonforced dose escalation < or = 240 microg) or placebo via sc injection three times a day before meals.
Report a problemFND-1750489407
08HumanRandomized controlled trialEfficacy outcome
In obese subjects, overall well-being improvement was reported by 52% with pramlintide versus 17% with placebo.
In plain wordsIn obese subjects, improved well-being was more common with pramlintide than placebo.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseReported well-being improvement
Study
n: not reported in source
Comparator
Placebo
Outcome group
Quality of life · Whole body
Studied dose
Nonforced escalation to 240 microg three times daily · subcutaneous · 16 weeksAs given in this study (human).
Measurements
Well-being improvement
52%
pramlintide
Well-being improvement
17%
placebo
Source sentences
Summary
More pramlintide than placebo-treated subjects reported improvements in appetite control (72% vs. 31%), weight control (63% vs. 24%), and overall well-being (52% vs. 17%).
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study.
Summary · context
For 16 wk, without concomitant lifestyle intervention, subjects self-administered pramlintide (nonforced dose escalation < or = 240 microg) or placebo via sc injection three times a day before meals.
Report a problemFND-1750489408
09HumanRandomized controlled trialSafety outcome
In obese subjects, the pramlintide study observed no unexpected safety signals.
In plain wordsIn obese subjects, the study that tested pramlintide reported no unexpected safety signals.
Peptide
Pramlintide (Symlin)
Outcome
Not applicableUnexpected safety signals
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Nonforced escalation to 240 microg three times daily · subcutaneous · 16 weeksAs given in this study (human).
Source sentences
Summary
No unexpected safety signals were observed.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study.
Summary · context
For 16 wk, without concomitant lifestyle intervention, subjects self-administered pramlintide (nonforced dose escalation < or = 240 microg) or placebo via sc injection three times a day before meals.
Report a problemFND-1750489409
10HumanRandomized controlled trialSafety outcome
In obese subjects receiving pramlintide, mild transient nausea was the most common adverse event.
In plain wordsIn obese subjects receiving pramlintide, mild temporary nausea was the most common reported adverse event.
Peptide
Pramlintide (Symlin)
Outcome
Not applicableNausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Nonforced escalation to 240 microg three times daily · subcutaneous · 16 weeksAs given in this study (human).
Source sentences
Summary
The most common adverse event reported was mild, transient nausea.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study.
Summary · context
For 16 wk, without concomitant lifestyle intervention, subjects self-administered pramlintide (nonforced dose escalation < or = 240 microg) or placebo via sc injection three times a day before meals.
Report a problemFND-1750489410

Studies that did not test the peptide alone1

In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Pramlintide (Symlin).

11HumanNot a test of Pramlintide (Symlin) aloneObservational studyEfficacy outcome
In obese pramlintide recipients, weight loss was similar without and with nausea, at 3.6% and 3.9%, respectively.
In plain wordsIn obese subjects receiving pramlintide, weight loss was similar in those without nausea and those with nausea.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeWeight loss by nausea status
Study
n: not reported in source
Comparator
Pramlintide recipients reporting nausea
Outcome group
Body weight · Metabolic and weight
Measurements
Weight loss
3.6%
without nausea
Weight loss
3.9%
with nausea
Source sentences
Summary
Pramlintide-treated subjects not reporting nausea experienced weight loss similar to those who did (3.6 +/- 0.5% and 3.9 +/- 0.5%, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled, multicenter study.
Summary · context
For 16 wk, without concomitant lifestyle intervention, subjects self-administered pramlintide (nonforced dose escalation < or = 240 microg) or placebo via sc injection three times a day before meals.
In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).
Report a problemFND-1750489411

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

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.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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