Weight Loss Outcomes Among Early High Responders to Exenatide Treatment: A Randomized, Placebo Controlled Study in Overweight and Obese Women
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Abstract
Objective: As there is significant heterogeneity in the weight loss response to pharmacotherapy, one of the most important clinical questions in obesity medicine is how to predict an individual’s response to pharmacotherapy. The present study examines patterns of weight loss among overweight and obese women who demonstrated early robust response to twice daily exenatide treatment compared to those treated with hypocaloric diet and matched placebo injections. Methods: We randomized 182 women (BMI 25-48 kg/m2) to treatment with exenatide alone or matched placebo injections plus hypocaloric diet. In both treatment groups, women who demonstrated ≥ 5% weight loss at 12 weeks were characterized as high responders and those who lost ≥10% of body weight were classified as super responders. Our primary outcome was long-term change in body weight among early high responders to either treatment. An exploratory metabolomic analysis was also performed. Results: We observed individual variability in weight loss with both exenatide and hypocaloric diet plus placebo injections. There was a trend toward a higher percentage of subjects who achieved ≥ 5% weight loss with exenatide compared to diet (56% of those treated with exenatide, 76% of those treated with diet, p = 0.05) but no significant difference in those who achieved ≥ 10% weight loss (23% of individuals treated with exenatide and 36% of those treated with diet, p = 0.55). In both treatment groups, higher weight loss at 3 months of treatment predicted super responder status (diet p=0.0098, exenatide p=0.0080). Both treatment groups also demonstrated similar peak weight loss during the study period. We observed lower cysteine concentrations in the exenatide responder group (0.81 vs 0.48 p < 0.0001) and a trend toward higher levels of serotonin, aminoisobutyric acid, anandamide, and sarcosine in the exenatide super responder group. Conclusion: In a population of early high responders, longer term weight loss with exenatide treatment is similar to that achieved with a hypocaloric diet. Clinical Trial Registration: www.clinicaltrialsgov , identifier NCT01590433.
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These medications work through diverse mechanisms such as slowing of gastric emptying (GLP1 agonists), central sympathomimetic appetite suppression (phentermine), hypothalamic reward modulation (naltrexone/bupropion), and lipase inhibition (orlistat).
“These medications work through diverse mechanisms such as slowing of gastric emptying (GLP1 agonists), central sympathomimetic appetite suppression (phentermine), hypothalamic reward modulation (naltrexone/bupropion), and lipase inhibition (orlistat) [6,8,9,10,11].”
From Gastrointestinal Adverse Effects of Anti-Obesity Medications in Non-Diabetic Adults: A Systematic Review (2025) · cites this paper as [9]
Multiple trials reported that the most commonly observed AEs included nausea, diarrhea, constipation, and abdominal discomfort.
“Multiple trials reported the most commonly observed AEs included nausea, diarrhea, constipation, and abdominal discomfort [3,6,9,12,13].”
From Gastrointestinal Adverse Effects of Anti-Obesity Medications in Non-Diabetic Adults: A Systematic Review (2025) · cites this paper as [9]
Incretin-based therapies (semaglutide, liraglutide, exenatide) showed a clear dose-dependent increase in nausea and diarrhea across both trials and real-world datasets.
“Incretin-based therapies (semaglutide, liraglutide, exenatide) showed clear dose-dependent increase in nausea and diarrhea across both trials and real-world datasets [6,8,9,10,11].”
From Gastrointestinal Adverse Effects of Anti-Obesity Medications in Non-Diabetic Adults: A Systematic Review (2025) · cites this paper as [9]
Rodgers et al. reported exenatide-related nausea in 70% versus 25% of controls.
“Rodgers et al. reported exenatide-related nausea in 70% vs. 25% of controls and decreased appetite in 41% vs. 24%; no serious GI events occurred [9].”
From Gastrointestinal Adverse Effects of Anti-Obesity Medications in Non-Diabetic Adults: A Systematic Review (2025) · cites this paper as [9]
GLP-1 receptor agonists (semaglutide, liraglutide, exenatide, orforglipron) consistently produced the highest frequency of GI events among approved pharmacotherapies.
“GLP-1 receptor agonists (semaglutide, liraglutide, exenatide, orforglipron) consistently produced the highest frequency of GI events among approved pharmacotherapies [6,7,9,10,13].”
From Gastrointestinal Adverse Effects of Anti-Obesity Medications in Non-Diabetic Adults: A Systematic Review (2025) · cites this paper as [9]
Trials in which participants were pre-informed about likely GI symptoms, such as those by Rodgers et al. and Lundgren et al., reported higher adherence and lower dropout rates.
“Trials in which participants were pre-informed about likely GI symptoms, such as those by Rodgers et al. and Lundgren et al., reported higher adherence and lower dropout rates [9,10].”
From Gastrointestinal Adverse Effects of Anti-Obesity Medications in Non-Diabetic Adults: A Systematic Review (2025) · cites this paper as [9]
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- Authors
- Rodgers, M., Migdal, A. L., Rodríguez, T. G., Chen, Z.-Z., Nath, A. K., Gerszten, R. E., Kasid, N., Toschi, E., Tripaldi, J., Heineman, B., Phan, M., Ngo, L., Maratos-Flier, E., & Dushay, J.
- Affiliations
- Beth Israel Deaconess Medical Center (US)
- Corresponding author
- Dushay, Jody
- Venue
- Frontiers in Endocrinology
- Publisher
- Frontiers Media SA
- Published
- 2021-11-17
- Volume
- 12
- Pages
- 742873-742873
- ISSN
- 1664-2392 (ISSN-L)
- PMC
- PMC8635796
- OpenAlex
- W3214272568
- Cited by
- 24
- References
- 33
- Citations by year
- 2026: 2 · 2025: 7 · 2024: 5 · 2023: 8 · 2022: 2
- FWCI
- 2.19
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Frontiers in Endocrinology (publishedVersion, cc-by)
- medRxiv (acceptedVersion)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- AstraZeneca Pharma Poland
- Topics
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Regulation of Appetite and Obesity
- Keywords
- exenatide, obesity, overweight women, weight loss response, super-responders, hypocaloric diet, placebo injection, cysteine, metabolomics, anandamide, serotonin, alpha-aminoisobutyric acid, sarcosine
- MeSH terms
- Exenatide, Adult, Combined Modality Therapy, Cysteine, Diet, Reducing, Double-Blind Method, Female, Humans, Middle Aged, Obesity, Weight Loss, Body Mass Index, Treatment Outcome, Anti-Obesity Agents, Overweight, Metabolomics
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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